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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVrije Universiteit Brussel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be 18 years of age or older

Participants must be able to read and write in Dutch, French or English

AHI ≥ 15

Prescribed CPAP for the first time as a treatment for their OSA

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard OSA care

    Other intervention

    All people will undergo standard care.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: CPAP group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3-months after initiation of CPAP therapy

Secondary outcomes

1

CPAP adherence

Average CPAP use in hours per night as measured by the CPAP device

Time frame
3-months after initiation of CPAP therapy
2

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).

Time frame
Baseline
3

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

Time frame
6-months after initiation of CPAP therapy
4

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)

Time frame
3 and 6 months after initiation of CPAP therapy

Other outcomes

Sponsors and contacts

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