Sleep Health Program for Patients With Chronic Pain

NCT04299100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-10

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER
  • Unity Health Toronto

    collaborator OTHER
  • Women's College Hospital

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Frances Chung, MBBS FRCPC · UHN/ University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2021-09-28
Completion
2021-09-28

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04299100 on ClinicalTrials.gov