The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.

March 10, 2020 updated by: Universitair Ziekenhuis Brussel

The Impact of Cognitive Behavioral Therapy for Insomnia on CPAP Therapy Use and Drop Outs in Obstructive Sleep Apnea Syndrome Patients With Insomnia.

Patients follow the fully standard sleep test according to the normal procedure. This means that they undergo a polysomnography and fill in a questionnaire. If according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. If the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. If the patient agrees, the CPAP-therapy will be started as usual, simultaneously with CGT-i. The latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. Because of the design of this study (starting CGT-I as soon as possible after the diagnosis of OSAS) and the groups already planned for CBT-I, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. The patient comes for monitoring at set times.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients, male and female, with an OSAS diagnosed by full polysomnography and insomnia diagnosed by questionnaires.
  • Age between 18 and 75 years
  • Dutch as native language

Exclusion Criteria:

  • Patients younger than 18 years and older than 75 years
  • Patients with a burn-out
  • Patients with restless legs
  • Pregnant woman
  • Patients who work as shift workers
  • Patients with severe psychiatric disorder
  • Patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy
  • Patients with daily alcohol abuse (men > 3 drinks on any day or 14 per week, women > 2 drinks on any day or 7 per week)

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CPAP + CBT-i
Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.
Behavioral: Cognitive behavioural therapy for insomnia
a technique for treating insomnia without medications
NO_INTERVENTION: CPAP only
Patients suffering from OSAS and insomnia, but only treated with CPAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of drop-outs in patients participating in the study.
Time Frame: 12 weeks
Patiënt who don't use there CPAP anymore.
12 weeks
CPAP habituation in patients participating in the study.
Time Frame: 12 weeks
The speed of CPAP habituation is determined by reading the CPAP device.
12 weeks

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

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 (ACTUAL)

October 22, 2018

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143201836242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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