Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55, Brazil
NCT Number: NCT06017921
The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
São Paulo, 55, Brazil
The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive impairment of quality of sleep and quality of life compared to patients with insomnia or OSA alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with isolated OSA. The best therapeutic approach for patients with COMISA is still unclear. Hypnotics have not been tested among patients with COMISA and indication for CPAP.
The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months. In addition, the investigators will assess the effect eszopiclone on insomnia severity, quality of life, anxiety.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Time frame: 4 weeks
Compare the effect of Eszopiclone 3mg or placebo for 14 days on one-month CPAP adherence (use > 4 hours per night through Resmed program) after 4 weeks days.
Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis.
Time frame: 6 months
Compare the effect of Eszopiclone 3mg or placebo for 14 days on 6 months CPAP adherence (use > 4 hours per night through Resmed program), sleep quality, insomnia and anxiety through questionnaries.
Adherence to CPAP will be assess by the average number of hours of use (>=4h). The investigators will use Resmed's program for this analysis.
The sleep quality, insomnia and anxiety will be assess through questionnaires.
University of Sao Paulo General Hospital
Other
Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)
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