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

Primary Purpose

Obstructive Sleep Apnea, Insomnia

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Eszopiclone 3 mg
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring COMISA, Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Eszopiclone

Placebo

Arm Description

Eszopiclone 3mg at bed time for 14 days

Placebo at bed time for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2023
Last Updated
August 24, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06017921
Brief Title
Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Insomnia
Keywords
COMISA, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eszopiclone
Arm Type
Active Comparator
Arm Description
Eszopiclone 3mg at bed time for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo at bed time for 14 days
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 3 mg
Intervention Description
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Primary Outcome Measure Information:
Title
Short-term CPAP adherence (use > 4 hours per night through Resmed program)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro R Genta, MD.
Phone
551126615486
Email
prgenta@usp.br
Facility Information:
Facility Name
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
55
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro R Genta, MD
Phone
551126625486
Email
prgenta@usp.br

12. IPD Sharing Statement

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

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