Sleep Health Program for Patients With Chronic Pain

Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)

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 Overview

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

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, M5G 2A2
      • Toronto Rehab Institute (TRI)
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group; Participants randomized to the Control Group will receive usual care from their pain physician.
EXPERIMENTAL: Sleep Health Program - Suspected No/mild sleep apnea; Participants randomized to the Sleep Health Program with no/mild sleep apnea.	Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea; Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.; Other Names: Sleep Health group
EXPERIMENTAL: Sleep Health Program - Suspected Moderate/severe sleep apnea; Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.	Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea; Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea will receive the Self-Management for Sleep Care videos and digital materials, and be recommended for referral to a sleep clinic as part of standard of care.; Other Names: Sleep Health group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Sleep Health Program	Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.	8 weeks
Feasibility of Sleep Health Program	Proportion of participants at baseline, and who completed the follow-up visits at 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.	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.	6 months
Efficacy of Sleep Health Program on Insomnia Severity Index	Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity.	6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Unity Health Toronto; Women's College Hospital; MOUNT SINAI HOSPITAL
• Investigators: Principal Investigator: Frances Chung, MBBS FRCPC, UHN/ University Health Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2020
• Primary Completion (ACTUAL): September 28, 2021
• Study Completion (ACTUAL): September 28, 2021

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Sleep Apnea Syndromes; Chronic Pain
• Other Study ID Numbers: Version: Sep 15, 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No