States reporting difficulty with sleeping in 1979 - Europe PMC

OBSTRUCTIVE SLEEP APNEA: THERAPEUTIC COMPLIANCE* JAMES P. BAKER, and (by invitation) VINCENT ROSE, and CATESBY WARE NORFOLK

Disorders associated with sleep have assumed a major emphasis for practitioners of medicine and investigators over the past three decades. These disorders are common, with over fifty million adults in the United States reporting difficulty with sleeping in 1979 (1). Additionally approximately ten million sought medical advice for sleep disorders in that year. A small percentage of these people have obstructive apnea [OSA]. A national cooperative study of five thousand patients seen in sleep laboratories found 22% with sleep apnea (2). This clinical syndrome was initially reported in 1965 (3, 23) and has become frequently recognized since that time. The typical patient presents as an obese, hypertensive adult male with daytime sleepiness, a long history of snoring, sexual impotency, morning headaches and has noted or has been noted to have personality changes. The recognition of the symptom complex frequently precipitates referral for sleep study (polysomnography) with the findings of frequent apneic episodes which may take three forms: obstructive, with continuing respiratory effort without respiratory air movement; central, without continuing respiratory effort; or mixed episodes which begin with a central episode and are followed by an obstructive episode (3). The therapy for OSA has taken several forms: 1) Weight reduction 2) Drugs: protriptyline, progesterone, tryptophan (4-7); 3) Surgery: tracheostomy and uvulopalatopharyngoplasty (UPPP) (8, 9); and 4) Various appliances one of which is nasal continuous positive airway pressure (NCPAP) (10-18). This study was undertaken to evaluate the compliance of patients who were advised to use nasal C-PAP following the diagnosis of OSA established by polysomnography in a sleep laboratory in an open staffed community hospital. * From the Department of Internal Medicine, Eastern Virginia Medical School, Norfolk. ** Reprint requests to: Department of Internal Medicine, Eastern Virginia Medical School,

Hofheimer Hall, 825 Fairfax Avenue, Norfolk, VA 23507-1912. 224

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METHODS AND RESULTS All patients who agreed to a trial of nasal C-PAP following the diagnosis of OSA established in the Eastern Virginia Medical School/ Norfolk General Hospital Sleep Laboratory in 1986 and 1987 were contacted by telephone. These patients were requested to complete a telephone questionnaire given by one of the physicians associated with the laboratory. During the period from January of 1986 to August 1987 eight hundred and eighty-six studies were carried out in the laboratory. Of these, one hundred and ninety-one patients were found to have OSA. One hundred and three of these patients were prescribed a trial of nasal C-PAP. The remaining patients were treated with other forms of therapy. All obese patients were prescribed weight reduction. Sixty-eight patients actually tried nasal C-PAP. Thirty-five patients of the one hundred and three who refused nasal C-PAP did so following a demonstration trial in the laboratory. Sixty-eight patients were either initially tried on nasal CPAP in the laboratory and then instructed again at home by one of several respiratory care organizations or initially instructed by the home respiratory care service in the home setting. The patients have subsequently been restudied in the laboratory to adjust the nasal C-PAP device to the optimal pressure to minimize apneic episodes and hemoglobin desaturations. Of the sixty-eight patients who initially tried nasal CPAP, forty-eight (forty-two male, six female; mean age 48.4 years; range 10-75) were using the device when the questionnaire was completed. Fifteen patients had stopped using the device and five patients could not be contacted for follow-up. The average time on nasal C-PAP was 3.5 months (1-15 range). The reasons for discontinuing nasal C-PAP were problems with the mask, air flow around the mask, or no improvement in symptoms. The majority (twelve patients) had no specific reasons for not continuing using the device. Thirty-two (66%) of the patients using nasal C-PAP complained of nasal dryness or congestion. Fifteen (32%) patients did not have nasal congestion or dryness and two percent did not respond to the question. Twenty-six (54%) of the patients had other complaints which were generally related to the mask or noise from the device. A major concern has been the acceptance by the patients' spouse. Since nasal C-PAP usually completely stops snoring (19) and the new devices are very quiet spousal acceptance in our series was very high (64%). Of those patients who used the nasal C-PAP 30 (62%) used it every night all night long and others used varying times (Table I). Table II demonstrates sleep quality; thirty-six (75%) patients reported significant improvement indicating adequate rest and being alert and awake following sleep. A characteristic part of the sleep apnea syndrome is

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JAMES P. BAKER TABLE 1 Obstructive sleep apnea-therapeutic compliance 30 (62%) Nightly use 3 (6%) All but 1 hour 5 (10%) All but 2-5 hours 6 (12%) Alternately at night 4 (8%) Never used Placement 43 (90%) Self 3 (6%) Assistance How long did it take to get used to C-PAP? 8.33 (Mean) Days

TABLE 2

Obstructive sleep apnea-therapeutic compliance Sleep quality 36 (75%) Rested 8 (16%) Not rested 36 (75%) Alert and awake 5 (10%) Not alert/awake

personality change with many patients reporting difficulty relating to others (3). Twenty-four (50%) of our patients noted an improvement in interpersonal relations following C-PAP. Nineteen patients (40%) noted no change and five patients (10%) did not respond to this question. Thirty-five (73%) of the patients indicated that they were able to do their daily functions better. Ten patients (21%) indicated no change and three (6%) were equivocal. The majority of the patients were obese with an average weight of 228 pounds. Even though all patients were encouraged to lose weight there was no significant difference in weight over this follow-up period. The majority of the patients believed that the instruction they received in the use of C-PAP was adequate with forty-six patients (96%) indicating proper instruction. Many patients required more than one visit from the home care company to complete instruction. The time period for adjustment to C-PAP was short, an average of 8.3 days. Many patients indicated immediate acceptance. Most patients, forty-four (92%), indicated that they would recommend this type of therapy to a family member or friend if it were necessary. Since the C-PAP devices are small and portable we were interested in knowing if the devices were taken when traveling. Twenty-eight patients (58%) used nasal C-PAP when traveling, eleven patients (23%) did not, seven patients (15%) had not traveled.


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DISCUSSION Since the report of Sullivan in 1981 (17), many others have demonstrated the effectiveness of nasal C-PAP in treatment of sleep disorders (10, 22, 25, 26). The response has been demonstrated to be rapid in onset (10, 12, 15) and effective for long term use (13, 16, 20, 21). Minimal adverse side effects have been observed. The only reported contraindication is the lax larynx syndrome (22). The syndrome of sleep apnea is generally a long term or chronic problem (3, 17) and requires modalities which lend themselves to long term use. Weight reduction is a prime therapy; however, success is limited by poor patient compliance. Tracheostomy is very effective for treatment of OSA; it is less desirable for most patients for multiple obvious reasons. UPPP, a major surgical procedure, has a success rate of 44-68% for good results (9, 24, 28). The compliance of patients with a noninvasive effective therapy is extremely important in the selection of therapeutic modality. Several others have published compliance rates from 40-85% (20, 21, 25). These results are related to duration of use and other factors, particularly the activity of the patient follow-up program. Saunders indicates the importance of nightly continuous utilization citing his findings of rapid return of daytime sleepiness in patients after one night's cessation of therapy (27). The Sleep Disorders Center at the Eastern Virginia Medical School/ Norfolk General Hospital is located in the Norfolk General Hospital which is an open staffed community hospital. The community norm is that patients are referred for studies and returned to their referring physician for follow-up care. The referring physicians were contacted, usually by telephone with recommendations, along with a follow-up letter indicating the recommendations of a multidisciplinary Sleep Disorders Committee which reviews all of the cases studied weekly. The majority of those physicians have followed the recommendations of the Sleep Disorders Committee; however, some have not and thus this may have had an impact on the results of this study. There has been no consistent effort made to reinforce the therapeutic recommendations for patients by the Sleep Laboratory other than the requirement that patients return for a follow-up study on C-PAP for optimal C-PAP adjustment. Our study demonstrates that with minimal follow-up 70% of the patients who initially start nasal C-PAP will use it for significant periods of time. These patients generally tolerate the device well and 62% utilized the device all night. This is probably because they obtain significant subjective and objective improvement rather rapidly. The group of pa-

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tients who refused nasal C-PAP initially did so for reasons which were not obvious and were unrelated to the severity of sleep apnea or other factors that we could evaluate. They are, however, a significant percentage (34%) of the patients that we evaluated who had obstructive sleep apnea and therefore must be considered in the overall evaluation. The lack of weight reduction in our patients and in others is very discouraging in the face of life threatening illness associated with obesity and needs continuing study. In summary this study indicates that nasal C-PAP is an effective means of controlling OSA. It is fairly well tolerated in an unselected group of patients who received less than optimal outpatient follow-up. Further study is indicated to increase compliance and to increase weight reduction.

ACKNOWLEDGMENTS The authors express their thanks to Drs. Robert Orlino and Freddie Wilson for assistance in data collection. REFERENCES 1. Institute of Medicine. Report of a Study: Sleeping Pills, Insomnia, and Medical Practice. Washington, D.C.; U.S. National Academy of Sciences, 1979. 2. Coleman RM, Roffwarg HP, Kennedy SJ, et al. Sleep-wake disorders based on a polysomnographic diagnosis. JAMA 1982; 247: 997 3. Guilleminault C, Eldridge FL, Tilkian A, et al. Sleep apnea syndrome due to upper airway obstruction. Arch Intern Med 1977; 7: 296 4. Mathewson HS. Drug therapy for obstructive sleep apnea. Resp Care 1986; 31: 717 5. Clark RW, Schmidt HS, Schaal SF, et al. Sleep apnea: treatment with protriptyline. Neurology 1979; 29: 1287 6. Schmidt HS. L-tryptophan in the treatment of impaired respiration in sleep. Clin Resp Physiol 1983; 19: 625 7. Brownell LG, West P, Sweatman P, et al. Protriptyline in obstructive sleep apnea. New Engl J Med 1982; 307: 1037 8. Motta J, Guilleminault C, Schroeder JS, et al: Tracheostomy and hemodynamic changes in sleep-induced apnea. Ann Intern Med 1978; 89: 454 9. Fujita S, Conway W, Zorick F, et al. Surgical correction of anatomic abnormalities in obstructive sleep apnea syndrome: uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg 1981; 89: 923 10. Remission of severe obesity-hypoventilation syndrome after short-term treatment during sleep with nasal continuous positive airway pressure. National Health and Medical Research Council Doctoral Student. Am Rev Resp Dis 1985; 128: 177 11. Wilhoit SC, Brown ED, Suratt PM. Treatment of obstructive sleep apnea with continuous nasal airflow delivered through nasal prongs. Chest 1985; 2:170 12. Remmers JE, Sterling JA, Thorarinsson B, et al. Nasal airway positive pressure in patients with occlusive sleep apnea. Am Rev Resp Dis 1984; 130: 1152 13. Berthon-Jones M, Sullivan CE. Time course of change in ventilatory response to C02


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with long-term CPAP therapy for obstructive sleep apnea. Am Rev Resp Dis 1987; 135: 144 Sanders MH. Nasal CPAP effect on patterns of sleep apnea. Chest 1986: 839 Rajagopal KR, Bennett LL, Dillard TA, et al. Overnight nasal CPAP improves hypersomnolence in sleep apnea. Chest 1986; 90: 172 Rapoport DM, Sorkin B, Garay SM, et al. Reversal of the "Pickwickian Syndrome" by long-term use of nocturnal nasal-airway pressure. New Engl J Med 1982; 307: 931 Sullivan CE, Issa FG, Berthon-Jones M, et al. Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares. Lancet 1981; 4: 862 Rajagopal KR, Bennett LL, Dillard TA, et al. Overnight nasal CPAP improves hypersomnolence in sleep apnea. Chest 1986; 2: 172 Berry RB, Block AJ. Positive nasal airway pressure eliminates snoring as well as obstructive sleep apnea. Chest 1984; 84: 15 Schweitzer PK, Chambers GW, Birkenmeier N, et al. Nasal continuous positive airway pressure (CPAP) compliance at six, twelve, and eighteen months. Sleep Research 1987; 16: 186. (Abstract) Nino-Murcia G, Crowe C, Bliwise D, et al. Nasal CPAP: follow-up of compliance and adverse effects. Sleep Research 1987; 16: 398. (Abstract) Anderson APD, Alving J, Lildholdt T, et al. Obstructive sleep apnea initiated by a Lax Epiglottis - a contraindication for continuous positive airway pressure. Chest 1987; 4: 621 Guilleminault C, Silvestri R. Sleep, breathing, and the heart. CVP 1982; 3: 15 Hernandez SF. Palatopharyngoplasty for the obstructive sleep apnea syndrome: technique and preliminary report of results in ten patients. Am J Otolaryngol 1982; 3: 229 Sanders MH, Gruemd CA, Rogers RM. Patient compliance with nasal C-PAP therapy for sleep apnea. Chest 1986; 90: 330 Issa FG, Sullivan CE. Reversal of central sleep apnea using nasal C-PAP. Chest 1986; 90: 165 Sanders MH, Holzer BC. Does sleep apnea beget sleep apnea? Clin Res 1984; 32: 436A. Wetmore SJ, Scrima L, Snyderman NL, et al. Postoperative evaluation of sleep apnea after uvulopalatopharyngoplasty. Laryngoscopy 1986; 96: 738

DISCUSSION Thompson (Richmond): Thank you very much, Jim, for this interesting, informative and very important contribution. I have two questions. One has a bit of a historical angle: Should the phrase Pickwickian syndrome be used in describing your patients. Secondly, have you done any arterial blood gas studies in an attempt to demonstrate at that level the change in respiratory drive? Baker: The Pickwickian syndrome is one in which people are obese, they have daytime sleepiness and are thought to have a respiratory control mechanism abnormality. They are insensitive to O2,CO2 or both. They may or may not have the obstructive airway episodes. I have intentionally left that specific term out because, although the term describes the majority of the patients we see, many of the people do not classically follow the Pickwickian description. We have done arterial blood gases on these patients, but it's awfully hard to do an arterial puncture and have somebody remain asleep. In the patients who have severe difficulty - the world class apneic patients, the PO2'S go very low. In fact, saturation has fallen below 50% indicating a PO2 of 27-28. You wonder how people survive these episodes. Respiratory drive studies have been done by others. The CO2 response can be shown to improve rather dramatically after several nights of sleep in apnea patients who have had elevated C02's during the daytime.

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Bransome (Augusta): At the beginning of your talk, you talked about the central versus obstructive, and a mixture of the two. I'd like to ask, when you looked at an effective CPAP whether you could stratify differences in beneficial effects between those groups. But also being an endocrinologist, and not knowing the answer possibly because of sleepiness and inattentiveness during journal reading, there is a group of hypothyroid individuals who have sleep apnea that is corrected by making them euthyroid. There is also another group that may or may not exist, whereas I've encountered the hypothyroidism situation I've not the other - where progesterone is said to be helpful for effective therapy. What about the difference appropo all the C-PAP thyroid and progesterone in terms of central versus obstructive? Baker: The obstructive apnea responds much better to nasal C-PAP than does central apnea. There are some investigators who've said that central apnea does not respond to nasal C-PAP. There was a paper published last year in Australia by Dr. Sullivan in which he had treated eight patients with pure central sleep apnea and found that they had central sleep apnea only when in the supine position and that they could be corrected with nasal C-PAP. The majority of the reports with nasal C-PAP have not found remarkable improvement in the treatment of central apnea. You are quite correct that there are a number of endocrine syndromes which do present as patients with apnea, the one you mentioned hypothyroidism, another is acromegalia. These are generally obstructive because they have very large tongues and a lot of loose tissue in their nasopharynx. The Progesterone topic is very interesting. Dr. Harold Lyons reported in the mid 1960's that a number of people with the Pickwickian syndrome, would respond to treatment with progesterone. It works, but for a short time in our experience. That is, it works for a short period of time in people who have both obstructive and central apnea. It is not as effective for obstructive apnea as the C-PAP device. It has the additional feminizing effect thus males are somewhat reluctant to use it. Since the majority of our patients are male, that has been a problem for us. There are some other drugs which are helpful. Protriptolene, a drug which decreases REM sleep has been of help in some patients. L-tryptophan increases REM sleep and there are patients who have a majority of their apneic episodes either during REM or during non-REM sleep in which you might want to utilize one of those two drugs. The majority of the drugs have not had as long lasting effect as we would like. McIntosh (Lakeland): Dr. Baker, thank you for this very interesting addition to our therapy. But I gather that there is falloff of the acceptance of the G-PaP with time. This I presume is due to the drying of the nasal mucosa and the symptoms resulting from that. Could you give us some idea as to how much of a window we have in using this before you have to have some other method. I take it this would not be accepted for a lifelong use in these patients. Is that correct? Baker: Dr. McIntosh, that is one of the frustrating aspects of dealing with this problem. We are dealing with a lifelong illness and it's very frustrating to me to see patients with an illness which is life-threatening, primarily obesity, and being unable to impact on these patients to get them to reduce weight. Nasal C-PAP has been in use since 1981. The device that was demonstrated in the slide is very acceptable to patients. It has only been available for about a year. And so, we don't have the answer to your question with the exception of the fact that studies that have been done demonstrated that after the first six months, there's probably an eighty plus acceptance; after twelve months it falls off to about seventy and then after one and a half to two years it's fallen off to about 40%. Rosenow (Philadelphia): Do people ever die of this? Baker: It's amazing that more of them don't die. If you follow people, as I responded to Dr. Thompson's question, their PO2'8 fall extremely low; into the mid twenties and you would think that that would not be compatible with life. Also if you follow the times of death it frequently occurs in the early hours of the morning. Sleep apnea probably has something to do with that observation.