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Completed

NCT Number: NCT06017921

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, 55, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eszopiclone 3 mg

Drug

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

Placebo

Drug

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

Primary outcomes

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

    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.

Secondary outcomes

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

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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