Sleep Health Program for Patients With Chronic Pain
1 other identifier
interventional
40
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
July 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2021
CompletedDecember 10, 2021
December 1, 2021
1.2 years
November 18, 2019
December 9, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.
6 months
Efficacy of Sleep Health Program on Insomnia Severity Index
6 months
Study Arms (3)
Control Group
NO INTERVENTIONParticipants randomized to the Control Group will receive usual care from their pain physician.
Sleep Health Program - Suspected No/mild sleep apnea
EXPERIMENTALParticipants randomized to the Sleep Health Program with no/mild sleep apnea.
Sleep Health Program - Suspected Moderate/severe sleep apnea
EXPERIMENTALParticipants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.
Interventions
Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
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.
Eligibility Criteria
You may qualify if:
- Adult patients (≥18 years old) with cognitive capability
- 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).
You may not qualify if:
- Patients with chronic pain secondary to a neoplasm or metastasis
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- MOUNT SINAI HOSPITALcollaborator
- Unity Health Torontocollaborator
- Women's College Hospitalcollaborator
Study Sites (5)
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto Rehab Institute (TRI)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frances Chung, MBBS FRCPC
UHN/ University Health Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, University of Toronto
Study Record Dates
First Submitted
November 18, 2019
First Posted
March 6, 2020
Study Start
July 9, 2020
Primary Completion
September 28, 2021
Study Completion
September 28, 2021
Last Updated
December 10, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share