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

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ClinicalTrials.gov Identifier: NCT06017921
Recruitment Status : Recruiting
First Posted : August 30, 2023
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Pedro Rodrigues Genta, University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Insomnia Drug: Eszopiclone 3 mg Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: double-blind
Primary Purpose: Treatment
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)
Actual Study Start Date : August 24, 2023
Estimated Primary Completion Date : March 20, 2025
Estimated Study Completion Date : December 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Eszopiclone

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Eszopiclone
Eszopiclone 3mg at bed time for 14 days
 Drug: Eszopiclone 3 mg
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm
Placebo Comparator: Placebo
Placebo at bed time for 14 days
 Drug: Placebo
Patients starting CPAP treatment will be randomized to either Eszopiclone or Placebo arm


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06017921


Contacts
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Contact: Pedro R Genta, MD. 551126615486 prgenta@usp.br

Locations
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Brazil
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo Recruiting
Sao Paulo, Brazil, 55
Contact: Pedro R Genta, MD    551126625486    prgenta@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Pedro Rodrigues Genta, Principal Investigador, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT06017921    
Other Study ID Numbers: ComisaEszopiclone
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro Rodrigues Genta, University of Sao Paulo General Hospital:
COMISA
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs