Sleep Health Program for Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299100
• Other study ID #: Version: Sep 15, 2020
• Status: Completed
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: September 28, 2021

Study information

• Verified date: December 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain
• Sleep
• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Department of Anesthesia	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto Rehab Institute (TRI)	Toronto	Ontario
Canada	Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia	Toronto	Ontario
Canada	Women's College hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	MOUNT SINAI HOSPITAL, Unity Health Toronto, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Sleep Health Program	Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.	8 weeks
Primary	Feasibility of Sleep Health Program	Proportion of participants at baseline, and who completed the follow-up visits at 6 months.	6 months
Secondary	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
Secondary	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