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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
| Unity Health Toronto | OTHER |
| Women's College Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants randomized to the Control Group will receive usual care from their pain physician. | |
| Sleep Health Program - Suspected No/mild sleep apnea | Experimental | Participants randomized to the Sleep Health Program with no/mild sleep apnea. |
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| Sleep Health Program - Suspected Moderate/severe sleep apnea | Experimental | Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Health Program for Participants with No/Mild Sleep Apnea | Behavioral | Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Sleep Health Program | Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks. | 8 weeks |
| Feasibility of Sleep Health Program | Proportion of participants at baseline, and who completed the follow-up visits at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Efficacy of Sleep Health Program on Insomnia Severity Index |
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Inclusion Criteria:
The inclusion criteria are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Chung, MBBS FRCPC | UHN/ University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| Toronto Rehab Institute (TRI) |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Sleep Health Program for Participants with Moderate/Severe Sleep Apnea | Behavioral | 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. |
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Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity. |
| 6 months |
| Toronto |
| Ontario |
| M5G 2A2 |
| Canada |
| Women's College hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia | Toronto | Ontario | M5T2S8 | Canada |
| Mount Sinai Hospital, Department of Anesthesia | Toronto | Ontario | Canada |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |