Sleep Health Program for Patients With Chronic Pain
CompletedNot applicableNCT04299100
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Brief summary (from the registry)
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.
Study details
- Official title
- Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)
- Conditions
- Sleep Disordered Breathing
- Chronic Pain
- Sleep
- Interventions
- Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea
- Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
- Sponsor
- University Health Network, Toronto
- Collaborators
- MOUNT SINAI HOSPITAL; Unity Health Toronto; Women's College Hospital
- Start date
- 2020-07-09
- Primary completion
- 2021-09-28
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: The inclusion criteria are: * 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). Exclusion Criteria: * 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).
Canadian sites (5)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04299100