FibromyalgiaFM-OSANCT02717585
Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea
A study testing Continuous Positive Airway Pressure Therapy (CPAP) in people with Fibromyalgia and Obstructive Sleep Apnea, run by Women's College Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia, Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure Therapy (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Women's College Hospital
Toronto, Ontario, M5S 1B2
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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
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.
Read the 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.
- Conditions
- Fibromyalgia, Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure Therapy (CPAP)
- Keywords
- Continuous Positive Airway Pressure therapy, Chronic Pain, Sleep Disturbance
- Medical subject headings
- Fibromyalgia, Sleep Apnea, Obstructive, Chronic Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Positive Airway Pressure Therapy (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Sleep quality
Sleep Quality will be measured via the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ)
Measured: 6 months
Sleepiness
Sleepiness will be measured via the Epworth Sleepiness Scale (ESS)
Measured: 6 months
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)
Measured: 6 months
Inflammatory Marker
Measurement of serum levels of C-Reactive protein
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Lack of funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Frances Chung, MBBS,FRCPC, Principal investigator, University Health Network, Toronto Western Hospital and Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717585
- Sponsor's protocol ID
- 2015-0112-B
- Acronym
- FM-OSA
- Status last verified
- May 2018
- First submitted
- 17 Mar 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2306288Yunus 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.
PubMed 26138918Roizenblatt 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.
PubMed 21594765Fitzcharles 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.
PubMed 23748251Peppard 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.
PubMed 23589584Sepici 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.
PubMed 17589851Chung 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.
PubMed 22401881Khalid 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.
PubMed 22131606
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02717585
- Acronym / sponsor ID
- FM-OSA / 2015-0112-B
- Conditions
- Fibromyalgia, Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway Pressure therapy, Chronic Pain, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Continuous Positive Airway Pressure Therapy (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment Group (CPAP) |
Primary outcome
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.
4 secondary outcomes
Sleep quality
Time frame: 6 months
Sleepiness
Time frame: 6 months
Quality of Life (QoL)
Time frame: 6 months
Inflammatory Marker
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 2306288Wolfe 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.
- Background: PubMed 26138918Yunus 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.
- Background: PubMed 21594765Roizenblatt 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.
- Background: PubMed 23748251Fitzcharles 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.
- Background: PubMed 23589584Peppard 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.
- Background: PubMed 17589851Sepici 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.
- Background: PubMed 22401881Chung 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 publication: PubMed 22131606Khalid 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.
- The Official STOP-Bang WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, MBBS,FRCPC principal investigator
University Health Network, Toronto Western Hospital and Women's College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure Therapy (CPAP) in people with Fibromyalgia and Obstructive Sleep Apnea, run by Women's College Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717585, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.