Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-07-09
2021-09-28
Brief Summary
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Detailed Description
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A)Sleep Health Program Group Participants in this group will receive usual care from their pain physician. Participants will also receive the Self-Management for Sleep Care videos and digital materials. Participants with suspected moderate/severe sleep apnea as determined by oximetry, but who have not been diagnosed with sleep apnea prior to the study, will be recommended for referral to a sleep clinic as part of standard of care.
B)Control Group Participants in this group will receive usual care from their pain physician.
First follow up visit:
At 8 weeks after the initial visit, all participants will attend their first follow-up visit and complete the sleep, pain and functional questionnaires and 7-day sleep diary recording, and report any changes in medications.
Second follow up visit:
At 6 months after the initial visit, all participants will attend their second follow-up visit and complete the sleep, pain and functional questionnaires, 7-day sleep diary recording and report any changes in medications. Control participants will receive information provided by the Self-Management for Sleep Care program. Control participants with suspected undiagnosed moderate/severe sleep apnea will be recommended for referral to a sleep clinic as part of standard of care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Participants randomized to the Control Group will receive usual care from their pain physician.
No interventions assigned to this group
Sleep Health Program - Suspected No/mild sleep apnea
Participants randomized to the Sleep Health Program with no/mild sleep apnea.
Sleep Health Program for Participants with No/Mild Sleep Apnea
Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
Sleep Health Program - Suspected Moderate/severe sleep apnea
Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.
Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea will receive the Self-Management for Sleep Care videos and digital materials, and be recommended for referral to a sleep clinic as part of standard of care.
Interventions
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Sleep Health Program for Participants with No/Mild Sleep Apnea
Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea will receive the Self-Management for Sleep Care videos and digital materials, and be recommended for referral to a sleep clinic as part of standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with chronic non-cancer pain for \> 3 months
* Reports sleep disturbances such as difficulty falling asleep, staying asleep, or problems waking up too early (responds "Mild", "Moderate", "Severe", or "Very Severe" to items 1, 2, or 3 on the Insomnia Severity Index).
Exclusion Criteria
* Conditions potentially interfering with comprehension and delivery of informed consent, such as certain neurological or psychiatric disorders
* Patients with severe insomnia (Insomnia Severity Index ≥ 22)
* Restless legs syndrome
* Periodic limb movement disorder
* Sleep apnea
* Narcolepsy
* Seizure disorder
* Patients who are pregnant
* Currently undergoing a psychological treatment for insomnia
* Participants who require 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 (e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, pulmonary hypertension, hypercapnia respiratory failure).
18 Years
ALL
No
Sponsors
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MOUNT SINAI HOSPITAL
OTHER
Unity Health Toronto
OTHER
Women's College Hospital
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Dr. Frances Chung
Professor, University of Toronto
Principal Investigators
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Frances Chung, MBBS FRCPC
Role: PRINCIPAL_INVESTIGATOR
UHN/ University Health Network
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Rehab Institute (TRI)
Toronto, Ontario, Canada
Women's College hospital
Toronto, Ontario, Canada
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
Toronto, Ontario, Canada
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario, Canada
Countries
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Other Identifiers
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Version: Sep 15, 2020
Identifier Type: -
Identifier Source: org_study_id