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Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial.

CONTEXT: Insomnia is a prevalent health complaint in older adults. Behavioral and pharmacological treatments have their benefits and limitations, but no placebo-controlled study has compared their separate and combined effects for late-life insomnia. OBJECTIVE: To evaluate the clinical efficacy of behavioral and pharmacological therapies, singly and combined, for late-life insomnia. DESIGN AND SETTING: Randomized, placebo-controlled clinical trial, at a single academic medical center. Outpatient treatment lasted 8 weeks with follow-ups conducted at 3, 12, and 24 months. SUBJECTS: Seventy-eight adults (50 women, 28 men; mean age, 65 years) with chronic and primary insomnia. INTERVENTIONS: Cognitive-behavior therapy (stimulus control, sleep restriction, sleep hygiene, and cognitive therapy) (n = 18), pharmacotherapy (temazepam) (n = 20), or both (n = 20) compared with placebo (n = 20). MAIN OUTCOME MEASURES: Time awake after sleep onset and sleep efficiency as measured by sleep diaries and polysomnography; clinical ratings from subjects, significant others, and clinicians. RESULTS: The 3 active treatments were more effective than placebo at posttreatment assessment; there was a trend for the combined approach to improve sleep more than either of its 2 single components (shorter time awake after sleep onset by sleep diary and polysomnography). For example, the percentage reductions of time awake after sleep onset was highest for the combined condition (63.5%), followed by cognitive-behavior therapy (55%), pharmacotherapy (46.5%), and placebo (16.9%). Subjects treated with behavior therapy sustained their clinical gains at follow-up, whereas those treated with drug therapy alone did not. Long-term outcome of the combined intervention was more variable. Behavioral treatment, singly or combined, was rated by subjects, significant others, and clinicians as more effective than drug therapy alone. Subjects were also more satisfied with the behavioral approach. CONCLUSIONS: Behavioral and pharmacological approaches are effective for the short-term management of insomnia in late life; sleep improvements are better sustained over time with behavioral treatment.

Aged↗

Nasal dilator strip therapy for chronic sleep-maintenance insomnia and symptoms of sleep-disordered breathing: a randomized controlled trial.

To test the impact of nasal dilator strips (NDSs) on insomnia severity, sleep-disordered breathing (SDB) symptoms, sleep quality, and quality of life. Randomized, controlled trial of 4 weeks' duration. Community sample of nonobese, adults with a primary sleep complaint of chronic sleep-maintenance insomnia and mild to moderate SDB symptoms (treatment, n=42; control, n=38). Primary outcomes were four validated scales: Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Questionnaire (FOSQ), and Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). Secondary outcomes were sleep indices, nonrestorative sleep ratings, and SDB symptoms, assessed retrospectively and prospectively. Both groups received nonspecific education about sleep disorders. Treatment group also received a brief SDB education and nasal strip instructions. At 4 weeks' follow-up, the treatment group demonstrated significant (p=.0001), large improvements in ISI and PSQI (mean Cohen's d=1.18) and significant (p<.02), medium-sized improvements in FOSQ and QLESQ (mean d=0.51) compared to small, nonsignificant changes in control group (Cohen's d range=0.36-0.09). Treatment group change scores among all four primary variables were significantly correlated (mean r=0.50, p=0.01). Secondary prospective and retrospective outcomes showed medium to large improvements in treatment compared to controls for sleep indices (mean d=0.52 vs 0.28), nonrestorative sleep ratings (mean d=0.69 vs 0.11), and sleep breathing symptoms (mean d=0.47 vs 0.09). Significance was obtained for prospective sleep indices (p=0.01), retrospective, and prospective nonrestorative sleep ratings (p=0.003, <0.05), and retrospective sleep breathing symptoms (p=0.03). SDB education and NDSs demonstrated therapeutic efficacy in a select sample of insomnia patients with SDB symptoms. Replication of results requires placebo controls and objectively confirmed SDB cases.

Chronic Disease↗

Surgical therapy for severe refractory sleep apnea in infants and children: application of the airway zone concept.

Obstructive sleep apnea in children may result in hypoxia, right-sided heart failure, and sudden death. Children with craniofacial deformities and/or cerebral palsy are at high risk for the development of obstructive sleep apnea. Prompted by the excellent results obtained in adults when sleep apnea was managed by an aggressive surgical approach, we undertook a similar treatment philosophy in children. Twenty-eight patients representing four diagnostic groups were evaluated and operated on for severe upper airway obstruction: Down syndrome (n = 5), cerebral palsy (n = 12), Goldenhar syndrome (n = 4), and a mixed apnea group (n = 7). Tracheostomy was avoided in 25 of 28 patients (89 percent), with a marked decrease in apnea (median 90 percent) and hypopnea (median 87 percent) episodes. Tongue hyoid suspension and skeletal expansion procedures, which were the mainstay of treatment, were applied for the first time in children and adolescents with obstructive sleep apnea.

Adolescent↗

[Efficacy of demand of positive airway pressure therapy for treating obstructive sleep apnea syndrome].

UNLABELLED: The treatment of choice for obstructive sleep apnea syndrome (OSAS) is nasal continuous positive airway pressure (nCPAP). The precise level of pressure is adjusted by polysomnography. Devices to deliver pressure on demand have recently been designed to adapt the level of pressure to each respiratory cycle according to flow modification. OBJECTIVE: To compare the manual titering nCPAP system with that of demand continuous positive airway pressure (nDPAP) in patients diagnosed of OSAS. PATIENTS AND METHODS: Eighteen consecutive patients whose OSAS was diagnosed by conventional polysomnography were enrolled with apnea-hypopnea indexes over 10/hour (AHI > 10) and clinical symptoms of daytime drowsiness and/or cardiovascular risk factors. Titering polysomnographs were performed for all patients with nCPAP and with nDPAP and analyzed blindly. RESULTS: No significant differences between nCPAP and nDPAP were found in neurophysiological variables analyzed (sleep architecture, arousals, sleep efficiency) or in respiratory variables (AHI, oxygen saturation) with the exception of minimum SatO2 during REM sleep, which was significantly better with nCPAP (p < 0.03). Mean end pressure with nCPAP and mean pressure with nDPAP were similar; it is also worth noting that mean pressure was lower with nDPAP than with titered nCPAP pressure a mean 65.7 +/- 22% of the time. CONCLUSION: Automatic nDPAP is as effective as titered nCPAP for treating patients with OSAS.

Adult↗

Central sleep apnea after interrupting longterm acetazolamide therapy.

One month administration of acetazolamide (ACET) (at sea level) improves periodic breathing and decreases the number of central apneas (CA) (De Backer et al., 1995 Am. J. Respir. Crit. Care Med. 151, 87-91) in nonhypercapnic central apnea syndrome. It remains unclear whether cessation of therapy would provoke recurrence of symptoms. In the present study we evaluated the number of CA after 1 and 6 months interruption of ACET therapy. Eight patients with central sleep apnea were included [central apnea index (CAI) > 5 or apnea and hypopnea index (AHI) > 10 and obstructive apnea index (OAI) < 5]. Polysomnography was repeated once after 1 month treatment (N2), after 1 month off treatment (N3) and after 6 months off treatment. CAI (25 +/- 10 at N1) decreased during N2 (4 +/- 2) and N3 (5 +/- 3) and remained low after N4 (3 +/- 1). However an increase in the number of obstructive apneas and central hypopneas could be observed together with a shift from central apnea to hypopnea after N4. Maybe ACET induces a long lasting resetting of the CO2 threshold which is still present after interruption of the therapy.

Acetazolamide↗

[Sleep deprivation as a predictor of response to light therapy in major depression].

Light therapy (LT) is regarded as the treatment of choice for seasonal affective disorder (SAD). In nonseasonal depression the results of light therapy are nonconclusive. Sleep deprivation (SD), however, is effective in 50-60% of the patients with major depression. The predictive value of Total Sleep Deprivation (TSD) for the treatment outcome of antidepressiva has been already examined. Purpose of the present study was to test whether light therapy is more beneficial in TSD responders than in TSD nonresponders. 40 inpatients with major depressive disorder completed one night of TSD. Twenty TSD responders and 20 TSD nonresponders were randomly assigned to 14 days of bright light therapy (2500 lux, 7-9 a.m.) or 14 days of dim light therapy (red light 50 lux, 7-9 a.m.). Manova with repeated measurements revealed a significant difference in the course of depression over the time between TSD responders and nonresponders, but no significant difference between bright and dim light. Questions of placebo effect, of SAD and of personality variables as predictors of response to SD and LT are being discussed.

Adult↗