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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP group | People defined as obstructive sleep apnoea with or without chronic pain. They undergo standard care (CPAP therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard OSA care | Other | All people will undergo standard care. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nils Runge, MSc | Contact | +32 2 477 44 20 | nils.arno.andreas.runge@vub.be | |
| Olivier Mairesse, PhD | Contact | +32 2 629 25 16 | Olivier.mairesse@vub.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |