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

NCT04306835 | Unknown

• 1 other identifier: 143201836242
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The number of drop-outs in patients participating in the study.

  Patiënt who don't use there CPAP anymore.

  12 weeks

• CPAP habituation in patients participating in the study.

  The speed of CPAP habituation is determined by reading the CPAP device.

  12 weeks

Study Arms (2)

CPAP + CBT-i

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioural therapy for insomnia

CPAP only

NO INTERVENTION

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

Interventions

Cognitive behavioural therapy for insomnia BEHAVIORAL

a technique for treating insomnia without medications

CPAP + CBT-i

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1050, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Apnea, Obstructive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jasper Molenberghs

CONTACT

0494182014; jasper.molenberghs@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 13, 2020
• Study Start: October 22, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2019-03

Locations

BE (1)