Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea

NCT02717585 | Withdrawn

• 1 other identifier: 2015-0112-B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia; Obstructive Sleep Apnea

Keywords

Continuous Positive Airway Pressure therapy; Chronic Pain; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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.

  6 months

Secondary Outcomes (4)

• Sleep quality

  6 months

• Sleepiness

  6 months

• Quality of Life (QoL)

  6 months

• Inflammatory Marker

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Treatment Group (CPAP)

ACTIVE COMPARATOR

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)

Interventions

Continuous Positive Airway Pressure Therapy (CPAP) DEVICE

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.

Treatment Group (CPAP)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (8)

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

• Yunus MB. Editorial review: an update on central sensitivity syndromes and the issues of nosology and psychobiology. Curr Rheumatol Rev. 2015;11(2):70-85. doi: 10.2174/157339711102150702112236.

  PMID: 26138918 BACKGROUND

• Roizenblatt S, Neto NS, Tufik S. Sleep disorders and fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):347-57. doi: 10.1007/s11916-011-0213-3.

  PMID: 21594765 BACKGROUND

• Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.

  PMID: 23748251 BACKGROUND

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

  PMID: 23589584 BACKGROUND

• Sepici V, Tosun A, Kokturk O. Obstructive sleep apnea syndrome as an uncommon cause of fibromyalgia: a case report. Rheumatol Int. 2007 Nov;28(1):69-71. doi: 10.1007/s00296-007-0375-9. Epub 2007 Jun 23.

  PMID: 17589851 BACKGROUND

• Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.

  PMID: 22401881 BACKGROUND

• Khalid I, Roehrs TA, Hudgel DW, Roth T. Continuous positive airway pressure in severe obstructive sleep apnea reduces pain sensitivity. Sleep. 2011 Dec 1;34(12):1687-91. doi: 10.5665/sleep.1436.

  PMID: 22131606 RESULT

Related Links

• The Official STOP-Bang Website

MeSH Terms

Conditions

Fibromyalgia; Sleep Apnea, Obstructive; Chronic Pain; Parasomnias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Frances Chung, MBBS,FRCPC

  University Health Network, Toronto Western Hospital and Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: December 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)