An interventional study of Sleep Health Program for Participants with No/Mild Sleep Apnea and Sleep Health Program for Participants with Moderate/Severe Sleep Apnea in Sleep Disordered Breathing, Chronic Pain and Sleep, sponsored by University Health Network, Toronto. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
This is a pilot, prospective, randomized controlled trial of a novel sleep health program versus no sleep intervention in chronic pain patients. The Sleep Health program will consist of weekly home-based videos and digital materials termed "Self-Management for Sleep Care", which will provide participants with information on how to improve their sleep through education on sleep hygiene, relaxation training, and cognitive behavioural components. Patients will be also be screened through undiagnosed sleep apnea. For those determined to have suspected undiagnosed moderate or severe sleep apnea, they will be receive a recommendation for referral to a sleep clinic as part of standard of care. The study aims to evaluate the feasibility and effectiveness of the Sleep Health Program which includes the videos and digital materials and screening for sleep apnea in patients with chronic pain.
All participants will complete sleep, pain, and functional questionnaires. Additionally, all participants will undergo one overnight oximetry reading using the wristwatch pulse oximetry. Following these baseline assessments and questionnaires, participants will be randomized to either the control group or the Sleep Health Program.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 40 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are:
Exclusion Criteria:
Participants randomized to the Control Group will receive usual care from their pain physician.
Participants randomized to the Sleep Health Program with no/mild sleep apnea.
Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea
Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.
Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
Also known as: Sleep Health group
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.
Also known as: Sleep Health group
Feasibility of Sleep Health Program
Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.
Time frame: 8 weeks
Feasibility of Sleep Health Program
Proportion of participants at baseline, and who completed the follow-up visits at 6 months.
Time frame: 6 months
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.
Change from baseline in sleep scores on the Functional Outcomes of Sleep-10 questionnaire at 8 weeks and 6 months. Score range: 0-40, lower score indicates worse functional outcomes.
Time frame: 6 months
Efficacy of Sleep Health Program on Insomnia Severity Index
Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto