Status:
COMPLETED
Sleep Health Program for Patients With Chronic Pain
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
MOUNT SINAI HOSPITAL
Unity Health Toronto
Conditions:
Sleep Disordered Breathing
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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-ba...
Detailed Description
All participants will complete sleep, pain, and functional questionnaires. Additionally, all participants will undergo one overnight oximetry reading using the wristwatch pulse oximetry. Following the...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04299100
Start Date
July 9 2020
End Date
September 28 2021
Last Update
December 10 2021
Active Locations (5)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
Toronto Rehab Institute (TRI)
Toronto, Ontario, Canada, M5G 2A2
3
Women's College hospital
Toronto, Ontario, Canada, M5S 1B2
4
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
Toronto, Ontario, Canada, M5T2S8