Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Location status: Recruiting
NCT Number: NCT06834724
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brussels, 1090, Belgium
Location status: Recruiting
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
Secondary research questions Cross-sectional
Longitudinal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All people will undergo standard care.
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
Time frame: 3-months after initiation of CPAP therapy
Average CPAP use in hours per night as measured by the CPAP device
Time frame: Baseline
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).
Time frame: 6-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
Time frame: 3 and 6 months after initiation of CPAP therapy
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)
Time frame: 3 and 6 months after initiation of CPAP therapy
Measured using the Epworth sleepiness scale - 0-24 with 0 indicating no sleepiness and 24 severe sleepiness.
Time frame: 3 and 6 months after initiation of CPAP therapy
Measured using the Pittsburgh Sleep quality index total score (0-21 with 0 indicating good sleep quality and 21 very bad sleep quality)
Time frame: 3 and 6 months after initiation of CPAP therapy
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
Time frame: 3 and 6 months after initiation of CPAP therapy
Measured using the anxiety subscale of the Hospital Anxiety and Depression Scale - 0-21 with 0 being no anxiety and 21 being severe anxiety
Time frame: 3 and 6 months after initiation of CPAP therapy
Measured using the Short Form 36 (SF-36) subscales with 0 indicating worse status and 100 indicating better health status in a domain
Contact information is provided by the study sponsor or research team.
Nils Runge, MSc
CONTACT
Olivier Mairesse, PhD
CONTACT
Vrije Universiteit Brussel
Other
Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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