search
Back to results

Sleep Health Program for Patients With Chronic Pain

Primary Purpose

Sleep Disordered Breathing, Chronic Pain, Sleep

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep Health Program for Participants with No/Mild Sleep Apnea
Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • St. Michael's Hospital
  • Toronto Rehab Institute (TRI)
  • Women's College hospital
  • Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
  • Mount Sinai Hospital, Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Sleep Health Program - Suspected No/mild sleep apnea

Sleep Health Program - Suspected Moderate/severe sleep apnea

Arm Description

Participants randomized to the Control Group will receive usual care from their pain physician.

Participants randomized to the Sleep Health Program with no/mild sleep apnea.

Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 18, 2019
Last Updated
December 9, 2021
Sponsor
University Health Network, Toronto
Collaborators
MOUNT SINAI HOSPITAL, Unity Health Toronto, Women's College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04299100
Brief Title
Sleep Health Program for Patients With Chronic Pain
Official Title
Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
MOUNT SINAI HOSPITAL, Unity Health Toronto, Women's College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Chronic Pain, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants randomized to the Control Group will receive usual care from their pain physician.
Arm Title
Sleep Health Program - Suspected No/mild sleep apnea
Arm Type
Experimental
Arm Description
Participants randomized to the Sleep Health Program with no/mild sleep apnea.
Arm Title
Sleep Health Program - Suspected Moderate/severe sleep apnea
Arm Type
Experimental
Arm Description
Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health Program for Participants with No/Mild Sleep Apnea
Other Intervention Name(s)
Sleep Health group
Intervention Description
Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
Other Intervention Name(s)
Sleep Health group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Sleep Health Program
Description
Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.
Time Frame
8 weeks
Title
Feasibility of Sleep Health Program
Description
Proportion of participants at baseline, and who completed the follow-up visits at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.
Description
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.
Time Frame
6 months
Title
Efficacy of Sleep Health Program on Insomnia Severity Index
Description
Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Chung, MBBS FRCPC
Organizational Affiliation
UHN/ University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto Rehab Institute (TRI)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
Facility Name
Women's College hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Mount Sinai Hospital, Department of Anesthesia
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sleep Health Program for Patients With Chronic Pain

We'll reach out to this number within 24 hrs