InsomniaNCT04306835
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
A study testing Cognitive behavioural therapy for insomnia in people with Insomnia and Obstructive Sleep Apnea, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia, Obstructive Sleep Apnea, Cognitive Behavioral Therapy
- What is being tested?
- Cognitive behavioural therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Oct 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1050
Sonia De Weerdt, 024773890, sonia.deweerdt@uzbrussel.be
About this study
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.
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
- Being tested
- Cognitive behavioural therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy for insomniaBehavioural
a technique for treating insomnia without medications
| Study group | Role | What they receive |
|---|---|---|
| CPAP + CBT-i | Active comparator | Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia. Receives: Behavioral: Cognitive behavioural therapy for insomnia |
| CPAP only | No intervention | Patients suffering from OSAS and insomnia, but only treated with CPAP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of drop-outs in patients participating in the study.
Patiënt who don't use there CPAP anymore.
Measured: 12 weeks
CPAP habituation in patients participating in the study.
The speed of CPAP habituation is determined by reading the CPAP device.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start22 Oct 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306835
- Sponsor's protocol ID
- 143201836242
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04306835
- Acronym / sponsor ID
- 143201836242
- Conditions
- Insomnia, Obstructive Sleep Apnea, Cognitive Behavioral Therapy, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP + CBT-i | Active comparator | Behavioral: Cognitive behavioural therapy for insomniaPatients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia. |
| CPAP only | No intervention | –Patients suffering from OSAS and insomnia, but only treated with CPAP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy for insomniaa technique for treating insomnia without medications | Behavioural | CPAP + CBT-i |
Primary outcome
The number of drop-outs in patients participating in the study.
Time frame: 12 weeks
Patiënt who don't use there CPAP anymore.
CPAP habituation in patients participating in the study.
Time frame: 12 weeks
The speed of CPAP habituation is determined by reading the CPAP device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy for insomnia in people with Insomnia and Obstructive Sleep Apnea, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasper Molenberghs (0494182014, jasper.molenberghs@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of drop-outs in patients participating in the study. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.