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

NCT06017921 | Recruiting Phase 4

• 1 other identifier: ComisaEszopiclone
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Insomnia

Keywords

COMISA; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (2)

Eszopiclone

ACTIVE COMPARATOR

Eszopiclone 3mg at bed time for 14 days

Drug: Eszopiclone 3 mg

Placebo

PLACEBO COMPARATOR

Placebo at bed time for 14 days

Drug: Placebo

Interventions

Eszopiclone 3 mg DRUG

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

Eszopiclone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 55, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Central Study Contacts

Pedro R Genta, MD.

CONTACT

551126615486; prgenta@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: August 30, 2023
• Study Start: August 24, 2023
• Primary Completion: March 20, 2025
• Study Completion: December 20, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

BR (1)