Randomized controlled trial of variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS).

STUDY OBJECTIVE: To determine whether fixed-pressure or variable-pressure CPAP was preferred by patients and gave better outcomes in patients with the obstructive sleep apnea/hypopnea syndrome (OSAHS). DESIGN: Randomized blinded cross-over trial with 6 weeks of fixed and 6 weeks of variable-pressure CPAP. SETTING: Sleep center. PATIENTS: 200 consecutive consenting CPAP naïve patients with daytime sleepiness and > 15 apneas + hypopneas/h after an attended auto-CPAP titration night. INTERVENTIONS: CPAP therapy using the same device (Autoset Spirit) set for 6 weeks in fixed pressure mode and for 6 weeks in variable pressure mode, the order of therapies being randomized. MEASUREMENTS AND RESULTS: All measurements were recorded at the end of each limb by a researcher blind to treatment. These included symptoms, Epworth Score, CPAP usage, objective sleepiness by modified Osler test, vigilance and health related quality of life. A total of 181 of 200 patients completed the study. At the end of the study, patients expressed no significant difference in the primary outcome, patient preference, 72 patients preferring fixed and 69 preferring variable-pressure CPAP. Epworth score was lower on variable (9.5, SEM 0.4) than fixed-pressure CPAP (10.0, SEM 0.3; P = 0.031). Mean CPAP use was higher on variable (4.2, SEM 0.2 h/night) than fixed-pressure CPAP (4.0, SEM 0.2 h/night; P = 0.047). There were no other significant differences between treatments. CONCLUSIONS This study shows no difference in patient preference and only a marginal benefit of variable over fixed-pressure CPAP in OSAHS in terms of subjective sleepiness and CPAP use. The clinical value of this difference remains to be determined. CLINICAL TRIAL INFORMATION: Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS); Registration # ISRCTN43085025.http://www.controlled-trials.com//SRCTN43085025.

Sleepiness and sleep-related accidents in commercial bus drivers.

INTRODUCTION: Professional drivers are at high risk of sleepiness due to a combination of factors including shift work and obstructive sleep apnea/hypopnea syndrome (OSAHS), and sleepiness in professional drivers is highly dangerous. This study aimed to determine the prevalence of excessive daytime sleepiness and accident rates in bus drivers. MATERIALS AND METHODS: Drivers employed at bus depots within 30 miles of Edinburgh were given a sleep questionnaire. One thousand eight hundred fifty-four drivers were approached, and 677 (37%; 25 female) completed questionnaires with a 97% response rate among the 456 given directly to drivers by the researcher. RESULTS: Of the responding drivers, 133 (20% of total, 19% of researcher-delivered questionnaires) reported an Epworth sleepiness score >10. Eight percent of drivers reported falling asleep at the wheel at least once/month, and 7% having an accident, and 18% a near-miss accident due to sleepiness while working. DISCUSSION: This study shows a concerningly high rate of sleepiness and sleep-related accidents among bus drivers. Screening for OSAHS among commercial drivers needs to be seriously evaluated with some urgency.

Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.

PURPOSE: Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. PATIENTS AND METHODS: Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. RESULTS: CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CONCLUSION: CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.

Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice.

STUDY OBJECTIVES: Persistent insomnia, although very common in general practice, often proves problematic to manage. This study investigates the clinical effectiveness and the feasibility of applying cognitive behavior therapy (CBT) methods for insomnia in primary care. DESIGN: Pragmatic randomized controlled trial of CBT versus treatment as usual. SETTING: General medical practice. PARTICIPANTS: Two hundred one adults (mean age, 54 years) randomly assigned to receive CBT (n = 107; 72 women) or treatment as usual (n = 94; 65 women). INTERVENTION: CBT comprised 5 sessions delivered in small groups by primary care nurses. Treatment as usual comprised usual care from general practitioners. MEASUREMENTS AND RESULTS: Assessments were completed at baseline, after treatment, and at 6-month follow-up visits. Sleep outcomes were appraised by sleep diary, actigraphy, and clinical endpoint. CBT was associated with improvements in self-reported sleep latency, wakefulness after sleep onset, and sleep efficiency. Improvements were partly sustained at follow-up. Effect sizes were moderate for the index variable of sleep efficiency. Participants receiving treatment as usual did not improve. Actigraphically estimated sleep improved modestly after CBT, relative to no change in treatment as usual. CBT was also associated with significant positive changes in mental health and energy/vitality. Comorbid physical and mental health difficulties did not impair sleep improvement following CBT. CONCLUSION: This study suggests that trained and supervised nurses can effectively deliver CBT for insomnia in routine general medical practice. Treatment response to small-group service delivery was encouraging, although effect sizes were smaller than those obtained in efficacy studies. Further research is required to consider the possibility that CBT could become the treatment of first choice for persistent insomnia in primary healthcare.

Comparison of CPAP titration at home or the sleep laboratory in the sleep apnea hypopnea syndrome.

STUDY OBJECTIVES: Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS) is conventionally started after in-laboratory overnight titration. This use of sleep laboratory space is both costly and limits access for diagnostic studies. This study aimed to evaluate whether automated CPAP titration in the home produced patient outcomes equal to those following laboratory-based automated CPAP titration. The main outcomes were Epworth Sleepiness Scale score, objective daytime sleepiness (Oxford SLEep Resistance test or OSLER test), and CPAP use; we also performed quality-of-life questionnaires: Functional Outcomes of Sleep Questionnaire and SF-36. DESIGN: Prospective, randomized, single-blind, parallel-group, controlled trial SETTING: Regional sleep center and patients' homes. PATIENTS: Two hundred CPAP-naïve patients with OSAHS requiring CPAP treatment. INTERVENTIONS: One hundred patients were randomly assigned to a standard 1-night in-hospital CPAP titration and 100 to 3 nights' home CPAP titration and then issued with fixed pressure CPAP. Data were analyzed on an intention-to-treat basis. MEASUREMENTS AND RESULTS: The patient groups did not differ at baseline. The CPAP pressures defined at titration (mean+/- SEM: 10.6+/-0.2, 10.4+/-0.2 cm H20, p = .19), number of mask leaks, and initial acceptance rates were similar in the sleep-laboratory and home-titrated groups. At 3-month follow-up, there was no significant difference in CPAP use (mean+/-SEM: 4.39+/-0.25, 4.38+/-0.25 h/night; p > .9), Epworth Sleepiness Scale score (9.5+/-0.5, 8.5+/-0.5, p = .14), OSLER, Functional Outcomes of Sleep Questionnaire, or SF-36 between the sleep-laboratory and home-titrated groups. CONCLUSIONS: Home-based automated CPAP titration is as effective as automatic in-laboratory titrations in initiating treatment for OSAHS.

Clinical audit of subjects with snoring & sleep apnoea/hypopnoea syndrome fitted with mandibular repositioning splint.

Snoring and obstructive sleep apnoea/hypopnoea syndrome (OSAHS) are often treated with mandibular repositioning splints (MRS), but the efficacy and satisfaction of them has not been comprehensively addressed. A survey on the use of and satisfaction with MRS was posted to 177 patients referred by a hospital orthodontic department for custom-fitting of a MRS. Data were analysed using non-parametric techniques. The response rate was 81% (n=144). Responders (30F, 114M) had mean (SD) age of 51 (11) years, apnoea+hypopnoea index (AHI) of 24 (21) per hr and Epworth Score of 10 (5) at diagnosis, and had been supplied with their MRS a median 7 (IQR 5-11) months previously. Fifty of the 144 patients (35%) had been offered continuous positive airway pressure (CPAP) treatment but had declined or abandoned this. Self-reported MRS use was 5 (2) h/night, with 74 of the 144 patients (51%) continuing to use MRS at least occasionally at a median 7 months after fitting. Survival analysis showed 12% still using MRS at 12 months. Epworth score fell slightly with MRS therapy [-2.4 (3.5); P=0.005] and 7 daytime and 2 nocturnal symptoms improved in MRS users (all P<0.05). Marital satisfaction did not change with MRS. Problems preventing MRS use in 70 non-users included: non-retention (n=12), sore mouth (n=13) or jaw (n=7), difficulties falling asleep (n=10) or breathing (n=7), excessive salivation (n=4), dental damage (n=4) and other problems (n=3). Continued use of MRS therapy was associated with a higher number of teeth, low marital satisfaction perceived by partners and greater improvement in symptoms reported by patients and partners. Continuance with MRS may be low and linked to tolerance problems.

Improving CPAP use by patients with the sleep apnoea/hypopnoea syndrome (SAHS).

Though continuous positive airway pressure (CPAP) is the treatment of choice for the sleep apnoea/hypopnoea syndrome (SAHS), suboptimal adherence to CPAP is common. Internationally, some 5-50% of SAHS patients recommended for CPAP either reject this treatment option or discontinue within the first week, and 12-25% of remaining patients can be expected to have discontinued CPAP by 3 years. Biomedical investigations of patients' CPAP use reveal frequent adverse effects, weak prospective relationships between symptomatic or physiological disease severity and CPAP use, and moderate correlations between use and benefit. Relatively expensive high-technological interventions to improve CPAP use (e.g. "intelligent" CPAP, humidification) are the subject of several well-conducted studies favouring their effectiveness. More basic educational and behavioural supports, and low-technological interventions (e.g. chinstraps, mask re-fitting) appear valued, but are currently less rigorously evaluated. In other diseases with demanding treatment regimens, cognitive constructs including health attitudes and beliefs (health value, locus of control, chance, powerful others, self-efficacy) and mental and physical health status are significant predictors of adherence. The enhancement of multidisciplinary models with psychosocial interpretations may provide increased explanatory and interventional potential in models of CPAP use. While acknowledging the scarcity of evidence, a structured, multidisciplinary, cost-efficient model is suggested, containing educational, behavioural and technological components as basic support, and with high-expertise cognitive-behavioural intervention in more difficult cases of low CPAP use.

Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint.

Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p