Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea
WithdrawnNot applicableNCT02717585
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep disorders. In fact, insomnia and waking unrefreshed are currently considered part of the criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After undergoing further baseline questionnaires and investigations, patients confirmed to have FM with moderate to severe OSA will be randomized to one of two different treatments: 1) Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway Pressure (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the Chronic Pain Clinic only.
Study details
- Official title
- Effect of Continuous Positive Airway Pressure (CPAP) on Symptoms of Patients With Fibromyalgia Syndrome and Obstructive Sleep Apnea (OSA): A Prospective Randomized Controlled Clinical Trial
- Conditions
- Fibromyalgia
- Obstructive Sleep Apnea
- Interventions
- Device: Continuous Positive Airway Pressure Therapy (CPAP)
- Sponsor
- Women's College Hospital
- Collaborators
- University Health Network, Toronto
- Start date
- 2018-12
- Primary completion
- 2020-06
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Possesses cognitive and physical capability necessary to comprehend and complete the study questionnaires, as well as how to use CPAP machines. * Be proficient in English, reading and comprehension at a Grade 6 level (patient or accompanying person). * Be accessible for follow-up via interview appointments. * Be able to provide informed consent. * Has a Widespread Pain Index (WPI) score of ≥7 and Symptom Severity Score (SSS) of ≥5 OR a WPI 3-6 and SSS ≥9 according to 2010 American College of Rheumatology criteria for Fibromyalgia. * Constant pain scores over the past 8 weeks. * Newly diagnosed OSA patients with an AHI ≥15 OR AHI ≥5 on laboratory polysomnography with significant symptoms such as daytime sleepiness (Epworth Sleepiness Scale (ESS\>10), or nocturnal symptoms (frequent nocturnal awakenings). Exclusion Criteria: * Conditions potentially interfering with comprehension and delivery of informed consent or unwillingness to provide consent. * Psychiatric conditions interfering with necessary capability to comprehend and complete study questionnaires. * Non-English speaking. * Pregnant and lactating women. * Uncorrectable coagulopathy interfering with phlebotomy. * Contraindication to the application of a CPAP interface such as significant facial deformities, or skin lesions. * History of drug or alcohol dependence or abuse within the last 3 months. * History of primary pain disorders other than Fibromyalgia such as chronic pain disorder. * History of primary sleep disorders associated with daytime sleepiness other than OSA, such as narcolepsy. * Patients who do not meet the 2010 American College of Rheumatology Criteria for Fibromyalgia. * Patients with previously diagnosed OSA who are already on CPAP before the initiation of the study. * Patients receiving trigger point injections or intravenous lidocaine for pain treatment. * Patients requiring an urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines update e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, obstructive/restrictive lung disease, pulmonary hypertension, hypercapnic respiratory failure or pregnancy.
Canadian sites (2)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02717585