Chronic PainNCT06834724
Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea and Chronic Pain
An observational study of Chronic Pain and Obstructive Sleep Apnea, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The bidirectional link between sleep and pain is a widely accepted concept. While there has been much focus on this in recent years, studies investigating obstructive sleep apnoea (OSA) and chronic pain are still not very common, especially in context of continuous positive airway pressure (CPAP) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Obstructive Sleep Apnea
- What is being tested?
- Standard OSA care
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Mar 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The target group for the study consists of adult, Dutch, French or Englisch speaking patients who have been referred to the sleep clinic. These patients have been diagnosed with OSA and will start to receive CPAP treatment. They are included independent of their chronic pain status but some analyses will be done in sub-groups.
Who may be able to join
- Participants must be 18 years of age or older
- Participants must be able to read and write in Dutch, French or English
- Participants must be diagnosed with clinically relevant OSA and newly start CPAP treatment:
- AHI ≥ 15
- Prescribed CPAP for the first time as a treatment for their OSA
- Participants must have read and signed the ICF
Who cannot join
- Participants who are currently receiving CPAP treatment or have had a CPAP treatment in the last year
- Participant receiving CPAP for other conditions than OSA (e.g. Central Sleep Apnoea)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Linda Demoulin, 0°322 477 60 68, linda.demoulin@uzbrussel.be
About this study
Official title: Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea
The bidirectional link between sleep and pain is a widely accepted concept. While there has been much focus on this in recent years, studies investigating obstructive sleep apnoea (OSA) and chronic pain are still not very common, especially in context of continuous positive airway pressure (CPAP) therapy.
In this study, people recently diagnosed with OSA, a common sleep disorder, that are receiving a CPAP mask are asked to fill in questionnaires at baseline, 3- and 6-month follow-up. Data of people with and without chronic pain will be collected and we will use the data will allow us to answer a number of clinically relevant questions. The primary questions investigate the following: 1) The association of CPAP adherence and pain outcomes with CPAP therapy at 3-month follow-up; 2) The association of baseline Apnoea-Hyopnea-Index on pain outcomes with CPAP therapy at 3-month follow-up. Secondary questions investigate the relevance of co-morbid insomnia (COMISA), the influence of chronic pain on CPAP adherence and general clinical outcomes of CPAP therapy in people with chronic pain.
Read the detailed description
In this study, participants with obstructive sleep apnoea (OSA) that start continuous positive airway pressure (CPAP) treatment will be asked to fill in questionnaires at baseline and two follow-up time points (3 and 6 months after the start of CPAP treatment). This information, information on CPAP adherence and information from the polysomnography assessment every participant has undergone prior to starting CPAP will allow us to investigate relevant outcomes of CPAP therapy in people with chronic pain. The detailed research questions are the following:
Primary research questions Longitudinal
- Are average hours of CPAP use per night (continuous variable) associated with average pain intensity at 3-month follow-up in people with CP and OSA?
- Is AHI at baseline associated with average pain intensity at 3-month follow-up in people with CP and OSA?
Secondary research questions Cross-sectional
- Is there a difference in CPAP use in hours (measured at 3-month follow-up) between people with OSA-only, OSA and CP, OSA and comorbid insomnia (COMISA - defined via the Insomnia Severity Index ≥15) and COMISA with CP?
- What is the prevalence of CP in patients with clinically relevant OSA in a sleep clinic setting?
- Is there a difference in average pain intensity between people with OSA and CP and people with COMISA and CP?
Longitudinal
- What are the short- (3 months) and long-term (6 months) clinical outcomes (average pain intensity, fatigue, sleepiness, sleep quality, depression, anxiety, quality of life) of CPAP treatment for patients with clinically relevant OSA and comorbid CP?
- Does average pain intensity measured at 3 and 6-month follow-up differ between patients that show CPAP adherence (= use of CPAP for a minimum of four hours each night on at least 70% of the monitored nights) compared to patients with non-adherence (= use of CPAP for a less than four hours each night on at least 70% of the monitored nights)?
- Is average pain intensity at baseline a predictor for CPAP adherence in people with CP and comorbid clinically relevant OSA as measured at 3-month follow-up.
- Is there a difference in pain outcomes measured at follow-up points at 3 and 6 months between people with CP and COMISA compared to patients with only OSA and CP?
- Is there a difference in self-reported health status with CPAP therapy at 3 and 6-month follow-up between people with clinically relevant OSA and CP compared to those without CP?
- Are average hours of CPAP use per night (continuous variable) associated with average pain intensity at 6-month follow-up in people with CP and OSA?
- Is AHI at baseline associated with average pain intensity at 6-month follow-up in people with CP and OSA?
Sensitivity and subgroup analyses will analyse data for people with headaches and other chronic pain separately considering headaches to be a very common direct consequence of OSA.
- Conditions
- Chronic Pain, Obstructive Sleep Apnea
- Being tested
- Standard OSA care
- Keywords
- Chronic pain, Obstructive sleep apnoea, Obstructive sleep apnea, CPAP
- Medical subject headings
- Chronic Pain, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard OSA careOther
All people will undergo standard care.
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | People defined as obstructive sleep apnoea with or without chronic pain. They undergo standard care (CPAP therapy). Receives: Other: Standard OSA care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain during last 1 week
Participants are asked for the average pain they had during the last 1 week. They answer on a scale for 0-10 with 0 being no pain and 10 being the worst pain ever. This is a single question taken from the Brief Pain Inventory
Measured: 3-months after initiation of CPAP therapy
Secondary outcomes (9)
CPAP adherence
Average CPAP use in hours per night as measured by the CPAP device
Measured: 3-months after initiation of CPAP therapy
Prevalence of chronic pain in people with OSA undergoing CPAP treatment
Chronic pain defined as pain anywhere in the body that is present every day or most days for 3 months or longer and that regularly impairs quality of life or ability to do activities (leisure, work).
Measured: Baseline
Average Pain during last 1 week
Participants are asked for the average pain they had during the last 1 week. They answer on a scale for 0-10 with 0 being no pain and 10 being the worst pain ever. This is a single question taken from the Brief Pain Inventory
Measured: 6-months after initiation of CPAP therapy
Fatigue (Mental and Physical)
Measured using the Brugmann Fatigue scale - 0-12 for each subscale (Mental fatigue and physical fatigue with 0 indicating no fatigue and 12 severe fatigue)
Measured: 3 and 6 months after initiation of CPAP therapy
Sleepiness
Measured using the Epworth sleepiness scale - 0-24 with 0 indicating no sleepiness and 24 severe sleepiness.
Measured: 3 and 6 months after initiation of CPAP therapy
Subjective sleep quality
Measured using the Pittsburgh Sleep quality index total score (0-21 with 0 indicating good sleep quality and 21 very bad sleep quality)
Measured: 3 and 6 months after initiation of CPAP therapy
Depression
Measured using the depression subscale of the Hospital Anxiety and Depression Scale - 0-21 with 0 being no depressive symptomatology and 21 being severe depressive symptomatology
Measured: 3 and 6 months after initiation of CPAP therapy
Anxiety
Measured using the anxiety subscale of the Hospital Anxiety and Depression Scale - 0-21 with 0 being no anxiety and 21 being severe anxiety
Measured: 3 and 6 months after initiation of CPAP therapy
Self-reported health status
Measured using the Short Form 36 (SF-36) subscales with 0 indicating worse status and 100 indicating better health status in a domain
Measured: 3 and 6 months after initiation of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Mairesse, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834724
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06834724
- Acronym / sponsor ID
- 1
- Conditions
- Chronic Pain, Obstructive Sleep Apnea
- Keywords
- Chronic pain, Obstructive sleep apnoea, Obstructive sleep apnea, CPAP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Feb 2025 (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.
The bidirectional link between sleep and pain is a widely accepted concept. While there has been much focus on this in recent years, studies investigating obstructive sleep apnoea (OSA) and chronic pain are still not very common, especially in context of continuous positive airway pressure (CPAP) therapy.
In this study, people recently diagnosed with OSA, a common sleep disorder, that are receiving a CPAP mask are asked to fill in questionnaires at baseline, 3- and 6-month follow-up. Data of people with and without chronic pain will be collected and we will use the data will allow us to answer a number of clinically relevant questions. The primary questions investigate the following: 1) The association of CPAP adherence and pain outcomes with CPAP therapy at 3-month follow-up; 2) The association of baseline Apnoea-Hyopnea-Index on pain outcomes with CPAP therapy at 3-month follow-up. Secondary questions investigate the relevance of co-morbid insomnia (COMISA), the influence of chronic pain on CPAP adherence and general clinical outcomes of CPAP therapy in people with chronic pain.
Detailed description
In this study, participants with obstructive sleep apnoea (OSA) that start continuous positive airway pressure (CPAP) treatment will be asked to fill in questionnaires at baseline and two follow-up time points (3 and 6 months after the start of CPAP treatment). This information, information on CPAP adherence and information from the polysomnography assessment every participant has undergone prior to starting CPAP will allow us to investigate relevant outcomes of CPAP therapy in people with chronic pain. The detailed research questions are the following:
Primary research questions Longitudinal
- Are average hours of CPAP use per night (continuous variable) associated with average pain intensity at 3-month follow-up in people with CP and OSA?
- Is AHI at baseline associated with average pain intensity at 3-month follow-up in people with CP and OSA?
Secondary research questions Cross-sectional
- Is there a difference in CPAP use in hours (measured at 3-month follow-up) between people with OSA-only, OSA and CP, OSA and comorbid insomnia (COMISA - defined via the Insomnia Severity Index ≥15) and COMISA with CP?
- What is the prevalence of CP in patients with clinically relevant OSA in a sleep clinic setting?
- Is there a difference in average pain intensity between people with OSA and CP and people with COMISA and CP?
Longitudinal
- What are the short- (3 months) and long-term (6 months) clinical outcomes (average pain intensity, fatigue, sleepiness, sleep quality, depression, anxiety, quality of life) of CPAP treatment for patients with clinically relevant OSA and comorbid CP?
- Does average pain intensity measured at 3 and 6-month follow-up differ between patients that show CPAP adherence (= use of CPAP for a minimum of four hours each night on at least 70% of the monitored nights) compared to patients with non-adherence (= use of CPAP for a less than four hours each night on at least 70% of the monitored nights)?
- Is average pain intensity at baseline a predictor for CPAP adherence in people with CP and comorbid clinically relevant OSA as measured at 3-month follow-up.
- Is there a difference in pain outcomes measured at follow-up points at 3 and 6 months between people with CP and COMISA compared to patients with only OSA and CP?
- Is there a difference in self-reported health status with CPAP therapy at 3 and 6-month follow-up between people with clinically relevant OSA and CP compared to those without CP?
- Are average hours of CPAP use per night (continuous variable) associated with average pain intensity at 6-month follow-up in people with CP and OSA?
- Is AHI at baseline associated with average pain intensity at 6-month follow-up in people with CP and OSA?
Sensitivity and subgroup analyses will analyse data for people with headaches and other chronic pain separately considering headaches to be a very common direct consequence of OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP group | – | Other: Standard OSA carePeople defined as obstructive sleep apnoea with or without chronic pain. They undergo standard care (CPAP therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target group for the study consists of adult, Dutch, French or Englisch speaking patients who have been referred to the sleep clinic. These patients have been diagnosed with OSA and will start to receive CPAP treatment. They are included independent of their chronic pain status but some analyses will be done in sub-groups.
Key inclusion criteria (6 listed)
- Participants must be 18 years of age or older
- Participants must be able to read and write in Dutch, French or English
- Participants must be diagnosed with clinically relevant OSA and newly start CPAP treatment:
- AHI ≥ 15
- Prescribed CPAP for the first time as a treatment for their OSA
Key exclusion criteria (2 listed)
- Participants who are currently receiving CPAP treatment or have had a CPAP treatment in the last year
- Participant receiving CPAP for other conditions than OSA (e.g. Central Sleep Apnoea)
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 |
|---|---|---|
| Standard OSA careAll people will undergo standard care. | Other | CPAP group |
Primary outcome
Average Pain during last 1 week
Time frame: 3-months after initiation of CPAP therapy
Participants are asked for the average pain they had during the last 1 week. They answer on a scale for 0-10 with 0 being no pain and 10 being the worst pain ever. This is a single question taken from the Brief Pain Inventory
9 secondary outcomes
CPAP adherence
Time frame: 3-months after initiation of CPAP therapy
Prevalence of chronic pain in people with OSA undergoing CPAP treatment
Time frame: Baseline
Average Pain during last 1 week
Time frame: 6-months after initiation of CPAP therapy
Fatigue (Mental and Physical)
Time frame: 3 and 6 months after initiation of CPAP therapy
Sleepiness
Time frame: 3 and 6 months after initiation of CPAP therapy
Subjective sleep quality
Time frame: 3 and 6 months after initiation of CPAP therapy
Depression
Time frame: 3 and 6 months after initiation of CPAP therapy
Anxiety
Time frame: 3 and 6 months after initiation of CPAP therapy
Self-reported health status
Time frame: 3 and 6 months after initiation of CPAP therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Obstructive Sleep Apnea, run by Vrije Universiteit 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 6 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nils Runge, MSc (+32 2 477 44 20, nils.arno.andreas.runge@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain during last 1 week (time frame: 3-months after initiation of CPAP therapy). 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 26 Sep 2025.