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

NCT ID: NCT04306835

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2020-03-31

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.

Conditions

Insomnia; Obstructive Sleep Apnea; Cognitive Behavioral Therapy; Continuous Positive Airway Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

CPAP + CBT-i

Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.

Group Type: ACTIVE_COMPARATOR

Cognitive behavioural therapy for insomnia

Intervention Type: BEHAVIORAL

a technique for treating insomnia without medications

CPAP only

Patients suffering from OSAS and insomnia, but only treated with CPAP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioural therapy for insomnia

a technique for treating insomnia without medications

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jasper Molenberghs

Role: CONTACT

jasper.molenberghs@vub.be

0494182014

Facility Contacts

Sonia De Weerdt

Role: primary

sonia.deweerdt@uzbrussel.be

024773890

Other Identifiers

143201836242

Identifier Type: -

Identifier Source: org_study_id