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Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea (FM-OSA)

Primary Purpose

Fibromyalgia, Obstructive Sleep Apnea

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Continuous Positive Airway Pressure Therapy (CPAP)

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Continuous Positive Airway Pressure therapy, Chronic Pain, Sleep Disturbance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Women's College Hospital
Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Treatment Group (CPAP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep quality

Sleep Quality will be measured via the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ)

Sleepiness

Sleepiness will be measured via the Epworth Sleepiness Scale (ESS)

Quality of Life (QoL)

QoL will be measured via both the revised Fibromyalgia Impact Questionnaire (FIQR) and the Short Form 12 Health Survey (SF-12)

Inflammatory Marker

Measurement of serum levels of C-Reactive protein

Full Information

NCT ID

NCT02717585

First Posted

March 17, 2016

Last Updated

May 17, 2018

Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02717585

Brief Title

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

Acronym

FM-OSA

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding available

Study Start Date

December 2018 (Anticipated)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Obstructive Sleep Apnea

Keywords

Continuous Positive Airway Pressure therapy, Chronic Pain, Sleep Disturbance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Arm Title

Treatment Group (CPAP)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Continuous Positive Airway Pressure Therapy (CPAP)

Intervention Description

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 Measure Information:

Title

Pain Score

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Sleep quality

Description

Sleep Quality will be measured via the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ)

Time Frame

6 months

Title

Sleepiness

Description

Sleepiness will be measured via the Epworth Sleepiness Scale (ESS)

Time Frame

6 months

Title

Quality of Life (QoL)

Description

QoL will be measured via both the revised Fibromyalgia Impact Questionnaire (FIQR) and the Short Form 12 Health Survey (SF-12)

Time Frame

6 months

Title

Inflammatory Marker

Description

Measurement of serum levels of C-Reactive protein

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frances Chung, MBBS,FRCPC

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's College Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 1B2

Country

Canada

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

2306288

Citation

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.

Results Reference

background

PubMed Identifier

26138918

Citation

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.

Results Reference

background

PubMed Identifier

21594765

Citation

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.

Results Reference

background

PubMed Identifier

23748251

Citation

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.

Results Reference

background

PubMed Identifier

23589584

Citation

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.

Results Reference

background

PubMed Identifier

17589851

Citation

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.

Results Reference

background

PubMed Identifier

22401881

Citation

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.

Results Reference

background

PubMed Identifier

22131606

Citation

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.

Results Reference

result

Links:

URL

http://www.stopbang.ca

Description

The Official STOP-Bang Website

Learn more about this trial

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

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