Web Based CBT-I in Patients With OSA and Insomnia

September 28, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA

Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial

Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. The presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is associated with OSA. After six month of treatment we will test the efficacy of web-based CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Novara
      • Veruno, Novara, Italy, 28013
        • Fabio Rossato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18
  • Apnea-Hypopnea Index (AHI) ≥5

Exclusion Criteria:

  • Complex sleep apnea
  • AHI >35
  • Psychiatric comorbidies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm of CBT-I treatment
Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.
Behavioral: web based cognitive-behavioral therapy
one web session of psycho-education about sleep
Other Names:
  • Arm of psycho-education session
Experimental: Arm of psycho-education session
Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use
Behavioral: web based cognitive-behavioral therapy
one web session of psycho-education about sleep
Other Names:
  • Arm of psycho-education session
No Intervention: Arm of control TAU (Treatment As Usual)
The control group will receive TAU. Each patient will start to use CPAP after the diagnosis according to AASM (American Academy of Sleep Medicine) guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity
Time Frame: Baseline
Assessed by Insomnia Severity Index
Baseline
Insomnia Severity
Time Frame: six months of CPAP use
Assessed by Insomnia Severity Index
six months of CPAP use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to CPAP therapy
Time Frame: six months of use
Hours of CPAP use during sleep with download of data
six months of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2021

Primary Completion (Estimated)

December 31, 2021

Study Completion (Estimated)

March 30, 2022

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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