Sleep Health Program for Patients With Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Sleep Disordered Breathing; Sleep
• Interventions: Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea; Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea

• Registration Number: NCT04299100
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-06
• Study Start: 2020-07-09
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Health Program - Suspected No/mild sleep apnea	Sleep Health Program for Participants with No/Mild Sleep Apnea	Participants randomized to the Sleep Health Program with no/mild sleep apnea.
Sleep Health Program - Suspected Moderate/severe sleep apnea	Sleep Health Program for Participants with Moderate/Severe Sleep Apnea	Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.

Primary Outcome Measures

Name	Time	Method
Feasibility of Sleep Health Program	6 months	Proportion of participants at baseline, and who completed the follow-up visits at 6 months.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Sleep Health Program on Insomnia Severity Index	6 months	Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity.
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.	6 months	Change from baseline in sleep scores on the Functional Outcomes of Sleep-10 questionnaire at 8 weeks and 6 months. Score range: 0-40, lower score indicates worse functional outcomes.

Trial Locations

Locations (5)

Mount Sinai Hospital, Department of Anesthesia; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia; 🇨🇦 Toronto, Ontario, Canada

Toronto Rehab Institute (TRI); 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Women's College hospital; 🇨🇦 Toronto, Ontario, Canada