Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea (FM-OSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02717585|
Recruitment Status : Withdrawn (Lack of funding available)
First Posted : March 23, 2016
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Obstructive Sleep Apnea||Device: Continuous Positive Airway Pressure Therapy (CPAP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Control Group
For the no intervention group (Control), patients will only receive standardized treatment for FM at the Pain Clinic. All patients will receive a multifaceted tailored regimen that incorporates one or more lines of pharmacological and/or non-pharmacological therapy. All assessment and management will be performed according to evidence-based therapeutic recommendations put forward by the Canadian Rheumatology Association and Canadian Pain Society.
Active Comparator: Treatment Group (CPAP)
In addition to standard FM treatment at the Pain Clinic, patients who are randomized to the treatment will meet with a sleep physician for possible therapy with a Continuous Positive Airway Pressure (CPAP) machine. A CPAP titration study will be arranged for in a laboratory setting, where in addition to the regular parameters of a diagnostic sleep study, CPAP will be titrated upwards starting from 5cm H2O to an optimal setting where the obstructive respiratory events are abolished. Patients will undergo regular follow-up as determined by their sleep physician. Adherence to CPAP treatment will be recorded at follow-up visits.
Device: Continuous Positive Airway Pressure Therapy (CPAP)
Continuous Positive Airway Pressure Therapy (CPAP) consists of a mask, fitted to the patient's face and hooked to a machine that generates positive pressure at the end of expiration to abolish obstructive apneic episodes during sleep.
- Pain Score [ Time Frame: 6 months ]Pain scores will measured on a Numerical Rating Scale (NRS) on the Brief Pain Inventory (BPI), reported at monthly intervals after allocation to a treatment group.
- Sleep quality [ Time Frame: 6 months ]Sleep Quality will be measured via the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ)
- Sleepiness [ Time Frame: 6 months ]Sleepiness will be measured via the Epworth Sleepiness Scale (ESS)
- Quality of Life (QoL) [ Time Frame: 6 months ]QoL will be measured via both the revised Fibromyalgia Impact Questionnaire (FIQR) and the Short Form 12 Health Survey (SF-12)
- Inflammatory Marker [ Time Frame: 6 months ]Measurement of serum levels of C-Reactive protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717585
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Frances Chung, MBBS,FRCPC||University Health Network, Toronto Western Hospital and Women's College Hospital|