Sleep ApneaNCT02279056
Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia
A study testing Self-help book for insomnia and Sleep hygiene advice in people with Sleep Apnea and Insomnia, run by University of Bergen at 1 site in Norway.
Trial summary
Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Insomnia
- What is being tested?
- Self-help book for insomnia and Sleep hygiene advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to 20 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with OSA and scheduled for CPAP treatment.
- Having co-morbid insomnia.
Who cannot join
- Less than 18 years of age
- Not fluent in Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia
Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.
Read the detailed description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP compliance.
- Conditions
- Sleep Apnea, Insomnia
- Being tested
- Self-help book for insomnia, Sleep hygiene advice
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help book for insomniaBehavioural
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
Sleep hygiene adviceBehavioural
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Self-help book | Experimental | A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity). Receives: Behavioral: Self-help book for insomnia |
| Sleep hygiene advice | Placebo comparator | A sheet of paper with sleep hygiene advice. Receives: Behavioral: Sleep hygiene advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Self-reported using a validated insomnia scale
Measured: 3 months
Secondary outcomes (3)
CPAP compliance
Using objective data from CPAP device
Measured: 3 months
Sleep apnea severity
Using objective apnea-hypopnea index from CPAP device
Measured: 3 months
Insomnia prevalence
Self-reported using a validated insomnia scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Bjorvatn, University of Bergen
- Investigators
- Bjørn Bjorvatn, MD PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279056
- Sponsor's protocol ID
- 02279056
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia
- ClinicalTrials.gov ID
- NCT02279056
- Acronym / sponsor ID
- 02279056
- Conditions
- Sleep Apnea, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- 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.
Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.
Detailed description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help book | Experimental | Behavioral: Self-help book for insomniaA self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity). |
| Sleep hygiene advice | Placebo comparator | Behavioral: Sleep hygiene adviceA sheet of paper with sleep hygiene advice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with OSA and scheduled for CPAP treatment.
- Having co-morbid insomnia.
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Not fluent in Norwegian
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 |
|---|---|---|
| Self-help book for insomniaRCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia. | Behavioural | Self-help book |
| Sleep hygiene adviceRCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia. | Behavioural | Sleep hygiene advice |
Primary outcome
Insomnia severity
Time frame: 3 months
Self-reported using a validated insomnia scale
3 secondary outcomes
CPAP compliance
Time frame: 3 months
Sleep apnea severity
Time frame: 3 months
Insomnia prevalence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Bjørn Bjorvatn, MD PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help book for insomnia and Sleep hygiene advice in people with Sleep Apnea and Insomnia, run by University of Bergen at 1 site in Norway.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2017. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: 3 months). 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 27 Oct 2017.