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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306835
• Other study ID #: 143201836242
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: March 2020

Study information

• Verified date: March 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Jasper Molenberghs
• Phone: 0494182014
• Email: jasper.molenberghs[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Continuous Positive Airway Pressure
• Insomnia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive behavioural therapy for insomnia
a technique for treating insomnia without medications

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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