David A Bradshaw1, Gregory A Ruff, David P Murphy. 1. Pulmonary Division, Department of Internal Medicine, Naval Medical Center San Diego, San Diego, CA 92134-1005, USA. DABradshaw@nmcsd.med.navy.mil
Abstract
BACKGROUND: Compliance with continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) is highly variable. Recent studies suggest that the initial experience with CPAP may determine long-term success. We hypothesized that administration of a hypnotic medication to new CPAP users would facilitate acclimation and increase usage. METHODS:Seventy-two male OSA patients referred for CPAP treatment were randomized to also receive an oral hypnotic agent (zolpidem), placebo pill, or neither (standard care) for the first 14 days of CPAP treatment. CPAP usage (effective mask pressure [hours per day]) was recorded by an internal data chip. Patient symptoms were assessed with the Epworth sleepiness scale (ESS) and functional outcomes of sleep questionnaire (FOSQ). Treatment groups were matched for age, body mass index, and baseline ESS and FOSQ scores. Despite randomization, the standard care group had a higher apnea/hypopnea index than either the zolpidem or placebo pill groups (54.75 +/- 28.02 vs 32.61 +/- 25.12 vs 38.09 +/- 25.65, p = 0.012) [mean +/- SD]. Compared to placebo pill and standard care groups, the zolpidem group did not show greater CPAP usage in terms of total days used (zolpidem, 20.58 +/- 7.40 days; placebo pill, 17.83 +/- 9.33 days; standard care, 22.92 +/- 6.95 days; p = 0.198) or average time used per night (4.43 +/- 1.16 h vs 4.23 +/- 2.14 h vs 4.94 +/- 1.44 h, p = 0.361). All groups showed significant symptom improvements on both the ESS (p < 0.001) and FOSQ (p < 0.05). CONCLUSION: Administration of an oral hypnotic agent did not improve initial CPAP compliance in men with OSA.
RCT Entities:
BACKGROUND: Compliance with continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) is highly variable. Recent studies suggest that the initial experience with CPAP may determine long-term success. We hypothesized that administration of a hypnotic medication to new CPAP users would facilitate acclimation and increase usage. METHODS: Seventy-two male OSA patients referred for CPAP treatment were randomized to also receive an oral hypnotic agent (zolpidem), placebo pill, or neither (standard care) for the first 14 days of CPAP treatment. CPAP usage (effective mask pressure [hours per day]) was recorded by an internal data chip. Patient symptoms were assessed with the Epworth sleepiness scale (ESS) and functional outcomes of sleep questionnaire (FOSQ). Treatment groups were matched for age, body mass index, and baseline ESS and FOSQ scores. Despite randomization, the standard care group had a higher apnea/hypopnea index than either the zolpidem or placebo pill groups (54.75 +/- 28.02 vs 32.61 +/- 25.12 vs 38.09 +/- 25.65, p = 0.012) [mean +/- SD]. Compared to placebo pill and standard care groups, the zolpidem group did not show greater CPAP usage in terms of total days used (zolpidem, 20.58 +/- 7.40 days; placebo pill, 17.83 +/- 9.33 days; standard care, 22.92 +/- 6.95 days; p = 0.198) or average time used per night (4.43 +/- 1.16 h vs 4.23 +/- 2.14 h vs 4.94 +/- 1.44 h, p = 0.361). All groups showed significant symptom improvements on both the ESS (p < 0.001) and FOSQ (p < 0.05). CONCLUSION: Administration of an oral hypnotic agent did not improve initial CPAP compliance in men with OSA.