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

Not Applicable

• Conditions: Obstructive Sleep Apnea; Insomnia; Continuous Positive Airway Pressure; Cognitive Behavioral Therapy
• Interventions: Behavioral: Cognitive behavioural therapy for insomnia

• Registration Number: NCT04306835
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Status Verified: 2019-03
• Study First Submitted: 2020-02-27
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP + CBT-i	Cognitive behavioural therapy for insomnia	Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.

Primary Outcome Measures

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

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium