Intensive Sleep RetrainingNCT06615336
Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia
A study testing Intensive Sleep retraining and Total Sleep Deprivation in people with Intensive Sleep Retraining and Total Sleep Deprivation, run by Laval University at 1 site in Canada.
Trial summary
The present study was designed to evaluate the efficacy of intensive sleep retraining for treating insomnia and explore its potential mechanisms of action. Specifically, it sought to determine whether the resolution of conditioned insomnia is the main therapeutic ingredient of intensive sleep retraining, or whether… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intensive Sleep Retraining, Total Sleep Deprivation, Control Condition
- What is being tested?
- Intensive Sleep retraining and Total Sleep Deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 30 Jul 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years old;
- Diagnosis of chronic insomnia based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria;
- Sleep onset latency ≥ 30 minutes for ≥ 3 nights per week for 2 weeks as measured by a daily sleep diary;
- Sleep efficiency ≤ 85% for 2 weeks as measured by a sleep diary;
- Significant distress or impairment of daytime functioning (score of at least 2 on item 5 or 7 of the Insomnia Severity Index);
- Have access to a computer with an Internet connection to complete questionnaires.
Who cannot join
- Active or unstable progressive medical condition (e.g., cancer) or degenerative neurological disease (e.g., dementia);
- Current diagnosis of major depression, dysthymia or anxiety disorders;
- Lifetime diagnosis of any psychotic or bipolar disorder;
- Other sleep disorders, sleep apnea (apnea/hypopnea index greater than 15) restless legs, or periodic limb movements during sleep (movement index with arousal greater than 15 per hour);
- Alcohol or substance use disorder in the past 12 months;
- Use of any drug known to affect sleep (e.g., cocaine) in the past 2 weeks;
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- Current or planned pregnancy during the study;
- Night shift work or irregular sleep pattern (e.g., usual bedtime after 2:00 a.m. or usual wake time after 10:00 a.m.);
- Current suicidal risk;
- Body mass index greater than 32;
- Use of sleep-inducing drugs (prescription or non-prescription);
- Use of tobacco products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia: a Randomized Controlled Trial
The present study was designed to evaluate the efficacy of intensive sleep retraining for treating insomnia and explore its potential mechanisms of action. Specifically, it sought to determine whether the resolution of conditioned insomnia is the main therapeutic ingredient of intensive sleep retraining, or whether the increase in homeostatic sleep drive due to sleep deprivation accounts for sleep improvements. To isolate those two components, this study compared the short and long-term efficacy of intensive sleep retraining and total sleep deprivation for the treatment of chronic insomnia in comparison to a control condition.
Read the detailed description
The pre-treatment period consisted of two consecutive weeks and was scheduled from Thursday to Thursday to coordinate the treatment period over the weekends. At the end of the pre-treatment period, participants were informed of their assignment to one of the three conditions. Participants were required to report to the sleep laboratory on Thursday at 7:00 p.m. for the night. Their time in bed was restricted to 6.5 hours (11:00 p.m. to 5:30 a.m.) to increase homeostatic sleep pressure before treatment. After waking up, participants were asked to leave the laboratory and could attend their normal daytime activities, but daytime naps were not allowed. All participants were asked to report to the laboratory at 7:00 p.m. on Friday.
Treatments
The 21-hour treatment period was scheduled from 11:00 p.m. on Friday to 8:00 p.m. on Saturday. Subjects in both the intensive sleep retraining and total sleep deprivation groups experienced at least 38.5 hours of sleep deprivation: Friday 5:30 a.m. through Saturday 8:00 p.m. Time was set aside to re-explain the protocol, answer questions, assess suicide risk again and calibrate the polysomnography montage. Participants were continuously monitored throughout the laboratory period to ensure that they were following the instructions specific to their condition. They were provided with breakfast, lunch, dinner, and snacks, but were not allowed to consume caffeine or alcohol, or to exercise. After the intensive sleep retraining and total sleep deprivation interventions, participants were not allowed to drive home for safety reasons and were instead picked up by a friend or family member or provided with a taxi voucher. There was no information about cognitive behavioral therapy for insomnia, sleep education, or sleep hygiene that was provided to any of the participants during the study.
Intensive Sleep Retraining : This treatment involved a series of 42 half-hour sleep onset opportunities repeated every 30 minutes starting at 11:00 p.m. At the beginning of each 30-minute period, participants were instructed to lie down in bed, close their eyes and relax. They were left alone in the bedroom, the lights were turned off, and the door was closed. The sleep period began when the lights were turned off. Once sleep onset was detected by the recording technician, participants were allowed to sleep for 2 to 4 consecutive minutes before being awakened. If participants did not fall asleep, the trial ended after 25 minutes, with a five-minute interval before the next sleep attempt. Participants were not given feedback about whether they fell asleep or not. Between trials, participants were instructed to get out of bed, leave the room, and either sit in a chair or stand in another room. They could talk with the experimenter or read but could not watch television or use a computer.
Total Sleep Deprivation : Participants were instructed to remain awake during the 21-hour treatment period. They could engage in quiet activities in the laboratory (e.g., reading, watching TV, using the computer) or talk with the experimenter. They could not sleep or stay in their bedrooms. A research assistant was always present to ensure that the participant did not sleep.
Control: Participants were allowed to sleep for up to 8 hours starting at 11:00 p.m. While awake, they could engage in quiet activities in the laboratory (e.g., reading, watching TV, using the computer) but were not allowed to sleep or stay in the bedroom during the day. They could attend a 1.5-hour information session about cognitive behavioral therapy for insomnia after completing the 1-month follow-up assessment.
Post-Treatment and Follow-up
Post-treatment period involved two consecutive weeks immediately after the treatment protocol. After the laboratory period, all participants were instructed to resume their normal sleep-wake schedule.
Follow-up consisted of one consecutive week of monitoring beginning 3, 7, and 11 weeks after the treatment period.
- Being tested
- Intensive Sleep retraining, Total Sleep Deprivation
- Keywords
- chronic insomnia, intensive sleep retraining, total sleep deprivation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Sleep retrainingBehavioural
Intensive Sleep Retraining treatment consisted of 42 sleep onset trials over a 21-hour sleep deprivation period
Total Sleep DeprivationBehavioural
Total Sleep Deprivation treatment consisted of an equivalent 21-hour sleep deprivation period without sleep onset trials
| Study group | Role | What they receive |
|---|---|---|
| Intensive Sleep retraining | Experimental | Not described Receives: Behavioral: Intensive Sleep retraining |
| Total Sleep deprivation | Experimental | Not described Receives: Behavioral: Total Sleep Deprivation |
| Control | No intervention | The control condition consisted of one night of habitual sleep in the laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
7-item patient-reported measure that assessed perceived severity of sleep difficulties, daytime impairments, and distress about sleep disturbances in the past month. A higher score (0-28) indicates more severe insomnia, within four severity categories: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).
Measured: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Secondary outcomes (6)
Visual analogue scales
Participants were asked to circle a number from 0 to 10 corresponding to their current state on each of the following dimensions: fully awake (0) to very sleepy (10); not at all irritable (0) to very irritable (10); not at all sad (0) to very sad (10); not at all happy (0) to very happy (10); not at all angry (0) to very angry (10).
Measured: During the treatment period, every hour from 8:00 a.m. to 8:00 p.m., for a total of 13 times.
Flinders Fatigue Scale
Self-reported and validated 7-item questionnaire that measured various characteristics of daytime fatigue experienced over the past two weeks. Higher scores (0-31) indicate greater fatigue.
Measured: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Patient Health Questionnaire
Self-reported and validated 9-item questionnaire that assessed nine symptoms of depression over the past two weeks. Total scores range from 0-27, with higher scores indicating more severe depressive symptoms, within five severity categories: none-minimal (0-4); mild (5-9); moderate (10-14); moderately severe (15-19); severe (20-27).
Measured: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Generalized Anxiety Disorder Scale
Self-reported and validated 7-item questionnaire that assessed seven symptoms of anxiety over the past two weeks. Total scores range from 0-21, with a higher score indicating more severe anxiety symptoms within four severity categories: minimal (0-4); mild (5-9); moderate (10-14); severe (15-21).
Measured: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Actigraphy
Ambulatory monitoring device that is placed on the wrist of participants to continuously record sleep-awake activity.
Measured: During the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.
Sleep diary
Self-reported measure of the following variables: bedtime, sleep onset latency, number and duration of nighttime awakenings, wake after sleep onset, sleep quality, daytime naps, use of medication and alcohol for sleep.
Measured: Daily during the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Nov 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Sleep RetrainingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Charles M. Morin, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615336
- Sponsor's protocol ID
- 2021-2015
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06615336
- Acronym / sponsor ID
- 2021-2015
- Keywords
- chronic insomnia, intensive sleep retraining, total sleep deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 26 Sep 2024 (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.
The present study was designed to evaluate the efficacy of intensive sleep retraining for treating insomnia and explore its potential mechanisms of action. Specifically, it sought to determine whether the resolution of conditioned insomnia is the main therapeutic ingredient of intensive sleep retraining, or whether the increase in homeostatic sleep drive due to sleep deprivation accounts for sleep improvements. To isolate those two components, this study compared the short and long-term efficacy of intensive sleep retraining and total sleep deprivation for the treatment of chronic insomnia in comparison to a control condition.
Detailed description
The pre-treatment period consisted of two consecutive weeks and was scheduled from Thursday to Thursday to coordinate the treatment period over the weekends. At the end of the pre-treatment period, participants were informed of their assignment to one of the three conditions. Participants were required to report to the sleep laboratory on Thursday at 7:00 p.m. for the night. Their time in bed was restricted to 6.5 hours (11:00 p.m. to 5:30 a.m.) to increase homeostatic sleep pressure before treatment. After waking up, participants were asked to leave the laboratory and could attend their normal daytime activities, but daytime naps were not allowed. All participants were asked to report to the laboratory at 7:00 p.m. on Friday.
Treatments
The 21-hour treatment period was scheduled from 11:00 p.m. on Friday to 8:00 p.m. on Saturday. Subjects in both the intensive sleep retraining and total sleep deprivation groups experienced at least 38.5 hours of sleep deprivation: Friday 5:30 a.m. through Saturday 8:00 p.m. Time was set aside to re-explain the protocol, answer questions, assess suicide risk again and calibrate the polysomnography montage. Participants were continuously monitored throughout the laboratory period to ensure that they were following the instructions specific to their condition. They were provided with breakfast, lunch, dinner, and snacks, but were not allowed to consume caffeine or alcohol, or to exercise. After the intensive sleep retraining and total sleep deprivation interventions, participants were not allowed to drive home for safety reasons and were instead picked up by a friend or family member or provided with a taxi voucher. There was no information about cognitive behavioral therapy for insomnia, sleep education, or sleep hygiene that was provided to any of the participants during the study.
Intensive Sleep Retraining : This treatment involved a series of 42 half-hour sleep onset opportunities repeated every 30 minutes starting at 11:00 p.m. At the beginning of each 30-minute period, participants were instructed to lie down in bed, close their eyes and relax. They were left alone in the bedroom, the lights were turned off, and the door was closed. The sleep period began when the lights were turned off. Once sleep onset was detected by the recording technician, participants were allowed to sleep for 2 to 4 consecutive minutes before being awakened. If participants did not fall asleep, the trial ended after 25 minutes, with a five-minute interval before the next sleep attempt. Participants were not given feedback about whether they fell asleep or not. Between trials, participants were instructed to get out of bed, leave the room, and either sit in a chair or stand in another room. They could talk with the experimenter or read but could not watch television or use a computer.
Total Sleep Deprivation : Participants were instructed to remain awake during the 21-hour treatment period. They could engage in quiet activities in the laboratory (e.g., reading, watching TV, using the computer) or talk with the experimenter. They could not sleep or stay in their bedrooms. A research assistant was always present to ensure that the participant did not sleep.
Control: Participants were allowed to sleep for up to 8 hours starting at 11:00 p.m. While awake, they could engage in quiet activities in the laboratory (e.g., reading, watching TV, using the computer) but were not allowed to sleep or stay in the bedroom during the day. They could attend a 1.5-hour information session about cognitive behavioral therapy for insomnia after completing the 1-month follow-up assessment.
Post-Treatment and Follow-up
Post-treatment period involved two consecutive weeks immediately after the treatment protocol. After the laboratory period, all participants were instructed to resume their normal sleep-wake schedule.
Follow-up consisted of one consecutive week of monitoring beginning 3, 7, and 11 weeks after the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Sleep retraining | Experimental | Behavioral: Intensive Sleep retraining |
| Total Sleep deprivation | Experimental | Behavioral: Total Sleep Deprivation |
| Control | No intervention | –The control condition consisted of one night of habitual sleep in the laboratory |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 60 years old;
- Diagnosis of chronic insomnia based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria;
- Sleep onset latency ≥ 30 minutes for ≥ 3 nights per week for 2 weeks as measured by a daily sleep diary;
- Sleep efficiency ≤ 85% for 2 weeks as measured by a sleep diary;
- Significant distress or impairment of daytime functioning (score of at least 2 on item 5 or 7 of the Insomnia Severity Index);
Key exclusion criteria (12 listed)
- Active or unstable progressive medical condition (e.g., cancer) or degenerative neurological disease (e.g., dementia);
- Current diagnosis of major depression, dysthymia or anxiety disorders;
- Lifetime diagnosis of any psychotic or bipolar disorder;
- Other sleep disorders, sleep apnea (apnea/hypopnea index greater than 15) restless legs, or periodic limb movements during sleep (movement index with arousal greater than 15 per hour);
- Alcohol or substance use disorder in the past 12 months;
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 |
|---|---|---|
| Intensive Sleep retrainingIntensive Sleep Retraining treatment consisted of 42 sleep onset trials over a 21-hour sleep deprivation period | Behavioural | Intensive Sleep retraining |
| Total Sleep DeprivationTotal Sleep Deprivation treatment consisted of an equivalent 21-hour sleep deprivation period without sleep onset trials | Behavioural | Total Sleep deprivation |
Primary outcome
Insomnia Severity Index
Time frame: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
7-item patient-reported measure that assessed perceived severity of sleep difficulties, daytime impairments, and distress about sleep disturbances in the past month. A higher score (0-28) indicates more severe insomnia, within four severity categories: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).
6 secondary outcomes
Visual analogue scales
Time frame: During the treatment period, every hour from 8:00 a.m. to 8:00 p.m., for a total of 13 times.
Flinders Fatigue Scale
Time frame: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Patient Health Questionnaire
Time frame: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Generalized Anxiety Disorder Scale
Time frame: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.
Actigraphy
Time frame: During the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.
Sleep diary
Time frame: Daily during the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.
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 26 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Sleep retraining and Total Sleep Deprivation in people with Intensive Sleep Retraining and Total Sleep Deprivation, run by Laval University at 1 site 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 6 inclusion and 12 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Insomnia Severity Index (time frame: At the end of the 2-week pre-treatment; at the end of the 2-week post-treatment; and at the end of each 1-week follow-up at the 1-, 2-, and 3-month.). 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 26 Sep 2024.