The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
Primary Purpose
Insomnia, Obstructive Sleep Apnea, Cognitive Behavioral Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive behavioural therapy for insomnia
Sponsored by
About this trial
This is an interventional supportive care trial for Insomnia
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)
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CPAP + CBT-i
CPAP only
Arm Description
Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.
Patients suffering from OSAS and insomnia, but only treated with CPAP.
Outcomes
Primary Outcome Measures
The number of drop-outs in patients participating in the study.
Patiënt who don't use there CPAP anymore.
CPAP habituation in patients participating in the study.
The speed of CPAP habituation is determined by reading the CPAP device.
Secondary Outcome Measures
Full Information
NCT ID
NCT04306835
First Posted
February 27, 2020
Last Updated
March 10, 2020
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04306835
Brief Title
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Obstructive Sleep Apnea, Cognitive Behavioral Therapy, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP + CBT-i
Arm Type
Active Comparator
Arm Description
Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.
Arm Title
CPAP only
Arm Type
No Intervention
Arm Description
Patients suffering from OSAS and insomnia, but only treated with CPAP.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy for insomnia
Intervention Description
a technique for treating insomnia without medications
Primary Outcome Measure Information:
Title
The number of drop-outs in patients participating in the study.
Description
Patiënt who don't use there CPAP anymore.
Time Frame
12 weeks
Title
CPAP habituation in patients participating in the study.
Description
The speed of CPAP habituation is determined by reading the CPAP device.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasper Molenberghs
Phone
0494182014
Email
jasper.molenberghs@vub.be
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia De Weerdt
Phone
024773890
Email
sonia.deweerdt@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
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