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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06017921

Enrollment

Registered

2023-08-30

Start date

2023-08-24

Completion date

2026-03-20

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Obstructive Sleep Apnea

Keywords

COMISA, Obstructive Sleep Apnea

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.

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.

Interventions

DRUGEszopiclone 3 mg

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Masking description

double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026