An interventional study of Intensive Sleep retraining and Total Sleep Deprivation in Intensive Sleep Retraining, Total Sleep Deprivation and Control Condition, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 36 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Behavioral: Intensive Sleep retraining
Behavioral: Total Sleep Deprivation
The control condition consisted of one night of habitual sleep in the laboratory
Intensive Sleep Retraining treatment consisted of 42 sleep onset trials over a 21-hour sleep deprivation period
Total Sleep Deprivation treatment consisted of an equivalent 21-hour sleep deprivation period without sleep onset trials
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).
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.
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).
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
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.
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
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).
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
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).
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
Ambulatory monitoring device that is placed on the wrist of participants to continuously record sleep-awake activity.
Time frame: 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.
Time frame: Daily during the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.
Plan to share: No
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