Clinical trial NCT04299100: Sleep Health Program for Patients With Chronic Pain
Official title: Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Chronic Pain
Sleep
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: Unity Health Toronto
name: Women's College Hospital
First posted: 2020-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility of Sleep Health Program
timeFrame: 8 weeks
measure: Feasibility of Sleep Health Program
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.
timeFrame: 6 months
measure: Efficacy of Sleep Health Program on Insomnia Severity Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehab Institute (TRI)
state: Ontario
city: Toronto
country: Canada
facility: Women's College hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Department of Anesthesia
state: Ontario
Study officials:
affiliation: UHN/ University Health Network
name: Frances Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
References: