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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Recruitment Status : Withdrawn (Lack of funding available)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
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure Therapy (CPAP) Not Applicable

Detailed Description:
Sleep, pain and breathing have a complex multidimensional relationship. Pain disturbs sleep, poor sleep alters the perception of pain and sleep is a vulnerable state of breathing. The central system sensitization affecting the sensation of widespread pain in FM is due to a decrease in the neurophysiologic inhibition of perception of painful stimuli. This is caused by disturbed sleep. Rheumatic disease pathology can be understood in the light of the interference of cytokines and cellular immune functions with the sleeping/waking brain. Sleep disturbances such as unrefreshing sleep, difficulty falling asleep and frequent night awakenings have been reported by over 90% of FM patients. Sleep disturbances may be related to depression through pain and alteration of physical functioning. Depression and sleep disturbances have been proven to contribute to fatigue in FM patients. Although non-restorative sleep and fatigue are the most commonly reported symptoms by FM patients, the exact cause of these problems is not well understood. A study reported that 50% of the women with obstructive sleep apnea syndrome or upper airway resistance syndrome had chronic pain and more than 11 tender points. One case report has suggested OSA as a possible cause for FM. No studies have been conducted to demonstrate the effect of CPAP treatment on symptoms of FM syndrome in patients with OSA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Sleepiness [ Time Frame: 6 months ]
    Sleepiness will be measured via the Epworth Sleepiness Scale (ESS)

  3. 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)

  4. Inflammatory Marker [ Time Frame: 6 months ]
    Measurement of serum levels of C-Reactive protein



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Women's College Hospital
University Health Network, Toronto
Investigators
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Principal Investigator: Frances Chung, MBBS,FRCPC University Health Network, Toronto Western Hospital and Women's College Hospital
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02717585    
Other Study ID Numbers: 2015-0112-B
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's College Hospital:
Continuous Positive Airway Pressure therapy
Chronic Pain
Sleep Disturbance
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases