Sleep Health Program for Patients With Chronic Pain
Sleep Health Program for Patients With Chronic Pain
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.
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).