Sleep Disordered BreathingNCT04299100
Sleep Health Program for Patients With Chronic Pain
A study testing Sleep Health Program for Participants with No/Mild Sleep Apnea and Sleep Health Program for Participants with Moderate/Severe Sleep Apnea in people with Sleep Disordered Breathing and Chronic Pain, run by University Health Network, Toronto at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Chronic Pain, Sleep
- What is being tested?
- Sleep Health Program for Participants with No/Mild Sleep Apnea and Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesCanada
- Study dates
- 9 Jul 2020to 28 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Rehab Institute (TRI)
Toronto, Ontario, M5G 2A2
Women's College hospital
Toronto, Ontario, M5S 1B2
Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Disordered Breathing, Chronic Pain, Sleep
- Being tested
- Sleep Health Program for Participants with No/Mild Sleep Apnea, Sleep Health Program for Participants with Moderate/Severe Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Health Program for Participants with No/Mild Sleep ApneaBehavioural
Also called Sleep Health group
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 ApneaBehavioural
Also called Sleep Health group
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants randomized to the Control Group will receive usual care from their pain physician. |
| Sleep Health Program - Suspected No/mild sleep apnea | Experimental | Participants randomized to the Sleep Health Program with no/mild sleep apnea. Receives: Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea |
| Sleep Health Program - Suspected Moderate/severe sleep apnea | Experimental | Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea. Receives: Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Sleep Health Program
Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.
Measured: 8 weeks
Feasibility of Sleep Health Program
Proportion of participants at baseline, and who completed the follow-up visits at 6 months.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start9 Jul 2020
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, Unity Health Toronto, Women's College Hospital
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, MBBS FRCPC, Principal investigator, UHN/ University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299100
- Sponsor's protocol ID
- Version: Sep 15, 2020
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2019
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)
- ClinicalTrials.gov ID
- NCT04299100
- Acronym / sponsor ID
- Version: Sep 15, 2020
- Conditions
- Sleep Disordered Breathing, Chronic Pain, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, Unity Health Toronto, Women's College Hospital
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants randomized to the Control Group will receive usual care from their pain physician. |
| Sleep Health Program - Suspected No/mild sleep apnea | Experimental | Behavioral: Sleep Health Program for Participants with No/Mild Sleep ApneaParticipants randomized to the Sleep Health Program with no/mild sleep apnea. |
| Sleep Health Program - Suspected Moderate/severe sleep apnea | Experimental | Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep ApneaParticipants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Health Program for Participants with No/Mild Sleep ApneaAlso: Sleep Health groupParticipants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials. | Behavioural | Sleep Health Program - Suspected No/mild sleep apnea |
| Sleep Health Program for Participants with Moderate/Severe Sleep ApneaAlso: Sleep Health groupParticipants 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. | Behavioural | Sleep Health Program - Suspected Moderate/severe sleep apnea |
Primary outcome
Feasibility of Sleep Health Program
Time frame: 8 weeks
Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.
Feasibility of Sleep Health Program
Time frame: 6 months
Proportion of participants at baseline, and who completed the follow-up visits at 6 months.
2 secondary outcomes
Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.
Time frame: 6 months
Efficacy of Sleep Health Program on Insomnia Severity Index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, MBBS FRCPC principal investigator
UHN/ University Health Network
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Health Program for Participants with No/Mild Sleep Apnea and Sleep Health Program for Participants with Moderate/Severe Sleep Apnea in people with Sleep Disordered Breathing and Chronic Pain, run by University Health Network, Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Sleep Health Program (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.