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(Chest. 2002;122:1156-1161.)
© 2002 American College of Chest Physicians

Home Sleep Studies in the Assessment of Sleep Apnea/Hypopnea Syndrome*

Rafael Golpe, MD; Antonio Jiménez, MD and Rosario Carpizo, MD

* From the Sleep Disorders Unit, Marqués de Valdecilla University Hospital, University of Cantabria, Santander, Spain.

Correspondence to: Rafael Golpe, MD, Rúa do Ensino 1-3 D, 32002 Orense, Spain; e-mail: rafa898{at}separ.es


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Objective: To determine the clinical utility of a limited sleep-recording device used unsupervised in the patient’s home, compared with in-laboratory, fully supervised polysomnography for the diagnosis of sleep apnea/hypopnea syndrome (SAHS), and to assess its impact on costs.

Design: Prospective case study.

Setting: The sleep-disorders unit of a tertiary referral university hospital.

Patients: Fifty-five patients suspected of having SAHS and living within 30 km of our laboratory.

Methods: Patients were studied first in their homes with the limited sleep-recording device. Polysomnography was performed within 30 days of the first study. Both studies were read by independent investigators blinded to the results of the other study. Diagnoses and therapeutic decisions regarding the use of continuous positive airway pressure obtained from the home and laboratory studies were compared. Agreement between the home and laboratory study recordings was also assessed using receiver operating characteristic (ROC) curves and Bland-Altman analysis. One half of the home studies were randomly assigned to be performed with a sleep technician’s set up of the equipment in the patient’s home (group 1), and the other half with the patient’s own setup of the sleep-recording device (group 2), after an instruction period in the hospital. An economic analysis was performed, considering the cost of repeating studies in cases with faulty or inconclusive home studies (these patients should undergo polysomnography as a second step).

Results: Seven percent of the home studies in group 1, and 33% in group 2 produced no interpretable data because of artifacts (p < 0.05). Sixteen percent of the home study findings were inconclusive. The diagnosis obtained from the limited sleep-recording device and polysomnography agreed in 75% of the interpretable home studies (89%, if inconclusive home studies were excluded). The area under the ROC curve for the home study-derived parameters was between 0.84 and 0.89, compared with polysomnography. There was no bias between home and polysomnography studies in the Bland-Altman plot. The cost per study of home study recordings was less expensive than that of polysomnography (143.86 euros), either with (93.08 euros) or without (129.97 euros) intervention of the technician in the patient’s home.

Conclusion: Home sleep studies are a viable form of diagnosing SAHS, and are less expensive than polysomnography. Intervention of a sleep technician in the patient’s home was the least expensive strategy, because of the high percentages of faulty studies with the patient’s own setup of the equipment, when using the limited sleep-recording device.

Key Words: home sleep study • limited sleep-recording device • polysomnography • sleep apnea syndromes


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Sleep apnea/hypopnea syndrome (SAHS) is a disorder with a high prevalence,1 which can be associated with significant morbidity and mortality, and with a higher risk of traffic accidents.2 It is accepted that conventional, fully supervised, in- laboratory polysomnography is the "gold standard" for the diagnosis of SAHS. However, the availability of polysomnography is limited in many areas, so long waiting lists are common, and costs are high.

Several limited, portable diagnostic devices for the assessment of sleep-related breathing disorders are commercially available. Some of these devices have been validated by comparing them with polysomnography.3 4 5 6 7 8 9 However, few studies have evaluated them when used in an unattended home setting, rather than in the sleep laboratory or in a respiratory ward.3 9 10 11 12 Our goal was to determine the usefulness of a portable recording device in the assessment of SAHS, when used unsupervised in the patients’ home.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Patients
Patients referred to our sleep-disorders unit for evaluation of suspected SAHS, who lived within 30 km of our hospital, were eligible. All patients had at least two of the following: loud snoring, observed apneas, and daytime drowsiness, and were judged by one of the authors (A.J.) to require a sleep study. Snoring and apneas were assessed using a questionnaire that was filled out by the patient. This questionnaire has been described elsewhere.13 Drowsiness was assessed using the Epworth sleepiness scale.14 An Epworth sleepiness scale score >= 11 was considered pathologic. Exclusion criteria were physical or mental impairment that precluded the use of the equipment. The symptoms of the patients were registered after the clinical interview, in a written document that was available for the investigator who analyzed the results of the home sleep study.

All patients who met the inclusion criteria were asked to participate in the study, and written informed consent was obtained. They were studied at their home with a portable recording device. The patients were randomly assigned to one of two groups: patients in group 1 were studied in their home with a technician’s intervention in the setup of the equipment. Patients in group 2 received a 15- to 20-min training period in the hospital provided by a technician, as well as written instructions regarding the use of the sleep-recording device. The latter group had the home study performed with the patient’s own setup of the equipment. The study was approved by our center’s ethical committee, and written informed consent was obtained from all the patients.

Home Sleep Study
This was carried out using a five-channel recording device (Apnoescreen-I; CNS-Jaëger; Höchberg, Germany). This device produces a computerized recording of variations in oronasal airflow (measured by thermistor), body position, wrist actimetry, pulse rate, and arterial oxygen saturation (measured by finger pulse oximetry). The device estimates the total sleep time from the wrist actimetry registry, eliminating from the total registry time those periods with high activity. It automatically calculates the number of apneas plus hypopneas (respiratory disturbances) per hour of estimated sleep time (automatic respiratory disturbance index). It also provides several parameters derived from the oximetry record; we analyzed the number of desaturations >= 4% per hour of estimated sleep time, and the cumulative percentages of sleep time at saturations < 90%.

Additionally, one of the authors (R.G.) carried out a manual analysis of the sleep-device recording of the home study, by counting in the screen of the computer the episodes of absence of airflow (apneas) and the episodes of drops in oronasal airflow that were followed by a desaturation (hypopneas). The graphic display of the sleep-recording device does not allow to measure manually with accuracy the level of desaturation. Therefore, no definite threshold for the desaturations was used, and we considered significant any discernible drop in saturation. The total number of apneas plus hypopneas was divided by the registry time and the sleep time in hours (as calculated by the equipment software), obtaining the manual respiratory disturbance index per hour of registry time (mRDI-r) and the manual respiratory disturbance index per hour of sleep time, respectively.

Polysomnography
Within 1 month from the date of the home sleep study, polysomnography was performed in the sleep laboratory. This included monitoring of EEG (C4/A1, C3/A2), chin electromyogram, electro-oculogram, ECG, thoracoabdominal movement by piezoelectric bands placed over the thorax and abdomen, oronasal flow by thermistor, tibial electromyograms, oxygen saturation with a finger sensor (Oxypleth; Novametrix Medical Systems; Wallingford, CT), body position, and snoring. All signals were recorded continuously in paper through a 14-channel polygraph (Medelec; Vickers Medical; Basingstoke, Hampshire, UK). One of the authors (R.C.) carried out the analysis of the polysomnography, blind to the result of the home study device recording. Polysomnography records were scored in 30-s epochs.

Apnea was defined as a complete cessation of airflow lasting >= 10 s. Hypopnea was defined as a discernible reduction in respiratory airflow lasting >= 10 s and accompanied by a decrease of >= 4% in oxygen saturation and/or an arousal. This definition of hypopnea is in accordance with the current guidelines of the Spanish Society of Pulmonology and Thoracic Surgery.15 The reason for counting "discernible" reductions in respiratory airflow instead of using a numerical threshold is that thermistors only allow a qualitative estimation of airflow.

The apnea-hypopnea index (AHI) was calculated as the average number of episodes of apnea and hypopnea per hour of sleep. Arousals were defined according to a report from the American Sleep Disorders Association Atlas task force.16 Sleep data were staged according to the system of Rechtschaffen and Kales.17

Data Analysis
The statistical analysis was made using a software package (NCSS; Hintze JL; Kaysville, UT). After analyzing the results of the home study recording, the studies was classified into one of three groups: (1) SAHS confirmed, (2) SAHS excluded, and (3) doubtful study (perform polysomnography). For this analysis, a mRDI-r >= 10 was considered suggestive of SAHS. After reviewing the patient’s symptoms, the investigator assigned the patients to one of two groups: (1) CPAP therapy indicated, or (2) CPAP therapy not indicated. Current guidelines of the Spanish Society of Pulmonology and Thoracic Surgery for the treatment of the SAHS were used.18

A cutoff point of 10 for the polysomnography-obtained AHI was used to diagnose SAHS. Most apneas and hypopneas in our patients were associated with respiratory effort, and there was no single patient in which central events predominated, so obstructive and central apneas were not distinguished for the analysis.

After the results of the polysomnography were available, the patient’s symptoms were reviewed and, according to the symptoms and polysomnography results, classified the patients into two groups: (1) receive CPAP treatment, or (2) not receive CPAP treatment, without knowing either the results of the home study recording or the decision regarding CPAP treatment made by the other investigator.

Concordance between the evaluators regarding diagnosis and CPAP treatment for the patients was evaluated. To simplify the current article, we did not analyze concordance between the authors regarding indication of other therapeutic modalities (uvulopalatopharyngoplasty, etc.) because there might be less general agreement between clinicians regarding these treatments.

To further evaluate the diagnostic usefulness of home study recordings, we carried out an analysis of the sensitivity and specificity of the parameters derived from the home sleep studies obtaining receiver operating characteristic (ROC) curves for a polysomnography-obtained AHI cutoff point of 10.19 Agreement between AHI and the parameters obtained from the home study recording was also analyzed according to the Bland and Altman method of concordance.20

Percentages were compared with use of the {chi}2 test, and means with Student t test. Normal distribution of the data were assessed with use of the Kolmogorov-Smirnov test. Nonparametric tests were used when the conditions for parametric tests were not fulfilled. A level of p < 0.05 was used for statistical significance.

Economic Analysis
In order to evaluate the likelihood of economic savings with both diagnostic approaches (home sleep studies with and without intervention of a sleep technician), compared with fully supervised polysomnography, we calculated the cost of the home studies and in-laboratory polysomnography.

Durán et al21 calculated the cost of in-laboratory polysomnography vs home limited sleep studies in our area. We used a similar methodology. In order to calculate the cost of polysomnography, we divided the cost of the polygraph (30,000 euros) by the number of sleep studies during its lifetime (assuming a 5-year lifetime and approximately 190 studies per year). We divided the cost of maintenance during 1 year by the number of studies per year. To calculate the cost of nurse time, we considered the monthly salary of a nurse specialized in sleep studies in our hospital, and divided it by the number of sleep studies per month. In our hospital, a physician is available during the night for managing any eventualities during sleep studies (this physician has no other clinical responsibilities outside the sleep laboratory); the monthly salary he receives for this task was divided by the number of studies per month. Another physician reads the next day the sleep studies. The cost of the study’s reading by the physician was estimated assuming about 1 h of physician’s time per polysomnography.

To evaluate the cost of the home sleep studies, we calculated the amount paid to the sleep technician for either setting up the equipment in the patient’s home or instructing the patient in the hospital. We assumed that there would be a number of faulty and/or inconclusive sleep studies. For the economic analysis, we decided that these patients should undergo supervised polysomnography as a second step. We calculated the number of polysomnographies that should have to be performed for each group of home sleep studies, related to the percentages of faulty/inconclusive studies in each group, and divided the added cost by the number of home sleep studies. We assumed about 0.5 h of physician’s time for reading each study. We also added the insurance cost for equipment used out of the hospital (dividing the total cost by the number of studies per year). The cost of the home sleep-recording device was estimated in 9,015 euros, and we also estimated a 5-year lifetime and 190 studies per year for the analysis.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
Unless otherwise indicated, results are expressed as mean ± SD. Fifty-nine patients were invited to participate in the study; 55 of them (93.2%) accepted. Twenty-eight patients were assigned to group 1 (home study recording performed with a technician’s set-up of the equipment), and 27 patients were assigned to group 2 (patient’s own setup of the home study device). Fifty-three patients were male, and 2 patients were female. Mean age was 52.7 ± 13.3 years. Mean body mass index was 30.3 ± 4.6. The interval of time between home study and polysomnography recordings was 10.9 ± 8.7 days. The total registry time was 6.73 ± 0.77 h for home study recordings and 7.56 ± 1.42 h for polysomnography.

Eleven home studies (20%) produced no interpretable data. Nine of these were studies performed with the patient’s own setup of the equipment. Three of these nine studies were unsuccessful because the patient failed to switch on the equipment. The other six studies were not interpretable because of poor signals or artifacts in the flow channel. In group 1 (technician’s setup of the equipment), the two unsuccessful studies were not interpretable because of poor signals in the flow channel.

Therefore, 7% of the home studies in group 1 were unsuccessful, while this percentage in group 2 raised to 33% (p < 0.05). There were no differences between patients with successful and unsuccessful studies regarding age (mean, 52.2 ± 13.7 years vs 55.1 ± 12.1 years, respectively; p = not significant), or body mass index (30.3 ± 4.6 vs 30.4 ± 5.03, respectively; p = not significant). All the patients with unsuccessful studies were male; however, as there were only two female participants, this fact is not significant.

Table 1 plots the diagnosis obtained from home study and polysomnography recordings. Both studies agreed in 33 cases (75% of the interpretable home studies). Seven home studies (16%) were inconclusive. If we exclude this seven studies from the analysis, the home study and polysomnography recordings agreed in 89% (33 of 37 studies) in which the home study suggested a "definitive" diagnosis.


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  		Table 1. Agreement Between Home Study and Polysomnography Results

 
Table 2 shows the concordance of the decision regarding CPAP treatment derived from home or full polysomnography studies. In 34 cases (77%), the clinical therapeutic decision after the home study agreed with that from polysomnography. We analyzed the 10 cases in which there was discrepancy regarding treatment. In six patients, the diagnosis suggested from both studies were different: three cases in which SAHS was diagnosed after the home study recording showed negative results when polysomnography was performed, and in three more cases the results were the opposite. In three cases in which the home study showed positive results (SAHS diagnosed), the polysomnography confirmed the diagnosis, but with less severity than suggested by the first study, so the investigator who analyzed the polysomnography did not considered indicated CPAP treatment. The last case, in which CPAP was not indicated after the home study but was suggested after polysomnography, was an inconclusive home study. If we exclude those cases with an inconclusive home study (in these cases, the decision of not treating with CPAP would have not been definitive), the therapeutic approach agreed in 76% (28 of 37 cases).


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  		Table 2. Agreement Between Therapeutic Decisions Derived From Home Study and Polysomnography Recordings

 
Table 3 shows the areas under the ROC curves for the home study indexes.22 There were no differences between the areas under the curves when the respiratory disturbances indexes were referred either to the registry time or to the estimated sleep time. The manual respiratory disturbance (either referred to the registry time or to the estimated sleep time) seemed the most useful indexes for the diagnosis of SAHS, as they had the larger area under the ROC curve, but the values obtained for the other indexes were too similar to assess if the difference was significant. Figure 1 shows the ROC curve for the mRDI-r.


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  		Table 3. Areas (SD) Under the ROC Curves for the Home Study Indexes, Referred to a Polysomnography-Obtained AHI >= 10*

 


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  		Figure 1. ROC curve for mRDI-r (MRDIR).

 
Figure 2 shows agreement between mRDI-r and polysomnography-obtained AHI using Bland and Altman method (comparing the difference between each pair of results with the mean value of each pair).20 Horizontal lines are drawn at the mean difference (- 4.2) ± 1.96 times the SD of the differences. Five cases were outside the limits of agreement.



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  		Figure 2. Bland-Altman plot for mRDI-r and AHI (see Fig 1 legend for definition of abbreviation).

 
Table 4 shows the results of the economic analysis. Home sleep studies were found to be less expensive than in-laboratory polysomnography. Home sleep studies with a technician’s setup of the equipment were found to be less expensive, because of the high percentages of faulty studies with the patient’s own setup of the sleep-recording device.


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  		Table 4. Cost per Study of In-laboratory Polysomnography and Home Sleep Studies*

 

   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
This study shows that a portable respiratory recording device used unsupervised in the patient’s home can be useful in the assessment of SAHS: 89% of the cases in which a "clear" diagnosis was suggested by the home study agreed with the results from fully supervised laboratory polysomnography.

There was less agreement between the clinical therapeutic decision made after home and laboratory studies, however, even when inconclusive home studies were excluded from the analysis. In about one third of the cases in which there was disagreement in the decision to treat with CPAP, the home study apparently overestimated the severity of SAHS, so it was decided to begin other alternative therapies after the polysomnography results were available (postural treatment, etc.). We did not analyze the long-term results of this therapies, so it remains to be established if the definitive treatment would have been CPAP also in these patients.

In two thirds of the cases in which there was no agreement in the therapeutic approach derived from both studies, there was a clear discrepancy in the diagnosis obtained with both methods. In three cases, they were clearly false-negatives of the home study, while in the other three cases they seemed to be false-positives of the home study. This might be controversial, however. Night-to-night variability can cause discrepancy between sleep studies (even between two full polysomnographies),23 particularly in those patients with milder SAHS.24 Also, it has been suggested that sleep efficiency could be better in the patient’s home than in the sleep laboratory, so it may be questionable that in-laboratory full polysomnography is really effective as a "gold standard’ for the diagnosis of SAHS.11 When Parra et al11 analyzed the validity of portable home studies in the diagnosis of SAHS, they considered that false-positives of the home study were actually true-positive studies missed by full polysomnography.

We have used the Apnoescreen-I for several years in the sleep laboratory, partially supervised by a technician, and we have found that the percentage of invalid recordings when used in this setting is about 5% (A. Jiménez, MD; personal observation; 1996 to 2001). In the present study, we found an unexpected high percentage (33%) of invalid recordings in the group of studies performed with the patient’s own setup of the equipment. Previous studies10 11 12 with a similar design to the present study have found lower (10 to 20%) percentages of faulty studies. The percentage of invalid studies in the group with a technologist’s intervention was significantly lower, suggesting that the cause of the defective recordings was the subject’s failure to properly operate the equipment. The reason for the high percentages of faulty recordings might be related to the relative complexity of the home study system, and might not apply to more simple devices. It also might be due to peculiarities in the subjects studied, which included a high number of residents in rural areas, who might not be familiarized with the use of electronic devices. Anyway, our results suggest that pilot studies with the particular equipment available are warranted when home sleep recordings are considered in clinical practice. The social level of the population referred to the sleep laboratory must be taken into account.

We have found that home sleep studies, either with or without intervention of a sleep technician in the patient’s home, are less expensive than in-laboratory polysomnography. Studies performed with a technician’s setup of the equipment were the least expensive, with this particular equipment, because of the high percentages of faulty studies when the patients were instructed to use the sleep-recording device in their homes. It must be noted that the cost analysis depends largely on the salaries paid in our area, which may vary considerably in other laboratories.

There are some other practical considerations that must be kept in mind before initiating home sleep studies. We have only included patients living within 30 km of our laboratory. This probably explains the high percentage of subjects who accepted to participate in the study. Portier et al12 report that, in their experience, patients living > 40 km from the hospital frequently prefer to be studied in the laboratory, rather than making two trips to the hospital. Another study25 has found problems in performing home polysomnography in some patients because of transportation difficulties. Having the home study performed with the intervention of a technician in patients who live far from the hospital would obviously limit the number of studies that could be performed per night, and would also increase costs. As Portier et al12 remark, the sleep center should take the population density surrounding the laboratory into account when planning a program of home studies.

In conclusion, unsupervised home sleep studies are a viable form of diagnosing SAHS. They are more economic than in-laboratory, fully supervised polysomnography, even with relatively high percentages of faulty or inconclusive recordings that lead to repeated studies. When using equipment with the complexity of the Apnoescreen-I in our population, the intervention of a sleep technician in the patient’s home was less expensive than instructing the patient at the hospital.


   Footnotes
 
Abbreviations: AHI = apnea/hypopnea index; CPAP = continuous positive airway pressure; mRDI-r = manual respiratory disturbance index per hour of registry time; ROC = receiver operating characteristic; SAHS = sleep apnea/hypopnea syndrome

Supported by a grant from Fundación Marqués de Valdecilla.

Received for publication November 30, 2001. Accepted for publication April 3, 2002.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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