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Completed

NCT Number: NCT04299100

Sleep Health Program for Patients With Chronic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Department of Anesthesia, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleep Health Program for Participants with No/Mild Sleep Apnea

Behavioral

Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.

Other names: Sleep Health group

Sleep Health Program for Participants with Moderate/Severe Sleep Apnea

Behavioral

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

Primary outcomes

  1. Feasibility of Sleep Health Program

    Time frame: 8 weeks

    Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.

  2. Feasibility of Sleep Health Program

    Time frame: 6 months

    Proportion of participants at baseline, and who completed the follow-up visits at 6 months.

Secondary outcomes

  1. Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.

    Time frame: 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.

  2. Efficacy of Sleep Health Program on Insomnia Severity Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • MOUNT SINAI HOSPITAL
  • Unity Health Toronto
  • Women's College Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2020
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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