Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06017921

Collaborator

(none)

Enrollment

Location

Arms

20.6

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Insomnia	Drug: Eszopiclone 3 mg Drug: Placebo	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Aug 24, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

May 11, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Eszopiclone Eszopiclone 3mg at bed time for 14 days	Drug: Eszopiclone 3 mg Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Placebo Comparator: Placebo Placebo at bed time for 14 days	Drug: Placebo Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Arm

Intervention/Treatment

Active Comparator: Eszopiclone

Eszopiclone 3mg at bed time for 14 days

Drug: Eszopiclone 3 mg

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Placebo Comparator: Placebo

Placebo at bed time for 14 days

Drug: Placebo

Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Outcome Measures

Primary Outcome Measures

Short-term CPAP adherence (use > 4 hours per night through Resmed program) [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.

Secondary Outcome Measures

Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinical diagnosis of Insomnia;
Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.

Exclusion Criteria:

Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use;
Use of hypnotics for more than 7 days in the last 2 months;
Renal dysfunction (serum creatinine >2mg/dL);
Severe liver or cardiac dysfunction;
Alcoholism;
Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.