Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea and Chronic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Obstructive Sleep Apnea
• Intervention / Treatment: Other: Standard OSA care

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

1. 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?
2. 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

1. 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?
2. What is the prevalence of CP in patients with clinically relevant OSA in a sleep clinic setting?
3. Is there a difference in average pain intensity between people with OSA and CP and people with COMISA and CP?

Longitudinal

1. 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?
2. 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)?
3. 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.
4. 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?
5. 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?
6. 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?
7. 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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Nils Runge, MSc; Phone Number: +32 2 477 44 20; Email: nils.arno.andreas.runge@vub.be
• Study Contact Backup: Name: Olivier Mairesse, PhD; Phone Number: +32 2 629 25 16; Email: Olivier.mairesse@vub.be

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Linda Demoulin; Phone Number: 0°322 477 60 68; Email: linda.demoulin@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPAP group; People defined as obstructive sleep apnoea with or without chronic pain. They undergo standard care (CPAP therapy).	Other: Standard OSA care; All people will undergo standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-months after initiation of CPAP therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP adherence	Average CPAP use in hours per night as measured by the CPAP device	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).	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	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)	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.	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)	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	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	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	3 and 6 months after initiation of CPAP therapy

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Chronic pain; CPAP; Obstructive sleep apnoea
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Sleep Apnea, Obstructive
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No