Obstructive Sleep ApneaPhase 4NCT06017921
Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA
A Phase 4 study testing Eszopiclone 3 mg in people with Obstructive Sleep Apnea and Insomnia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Insomnia
- What is being tested?
- Eszopiclone 3 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Aug 2023to 20 Mar 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Insomnia;
- Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55
About this study
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)
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Insomnia
- Being tested
- Eszopiclone 3 mg, Placebo
- Keywords
- COMISA, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eszopiclone 3 mgDrug
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
PlaceboDrug
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Active comparator | Eszopiclone 3mg at bed time for 14 days Receives: Drug: Eszopiclone 3 mg |
| Placebo | Placebo comparator | Placebo at bed time for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term CPAP adherence (use > 4 hours per night through Resmed program)
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.
Measured: 4 weeks
Secondary outcomes (1)
Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start24 Aug 2023
- Primary completion20 Oct 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Rodrigues Genta, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017921
- Sponsor's protocol ID
- ComisaEszopiclone
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No