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

Obstructive Sleep Apnea Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017921
• Other study ID #: ComisaEszopiclone
• Status: Recruiting
• Phase: Phase 4
• Start date: August 24, 2023
• Est. completion date: December 20, 2025

Study information

• Verified date: March 2024
• Source: University of Sao Paulo General Hospital
• Contact: Pedro R Genta, MD.
• Phone: 551126615486
• Email: prgenta[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2025
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Insomnia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eszopiclone 3 mg
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
• Placebo
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm

Locations

Country	Name	City	State
Brazil	Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	6 months