Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615336
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 700 pm for the night Their time in bed was restricted to 65 hours 1100 pm to 530 am 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 700 pm on Friday
Treatments
The 21-hour treatment period was scheduled from 1100 pm on Friday to 800 pm on Saturday Subjects in both the intensive sleep retraining and total sleep deprivation groups experienced at least 385 hours of sleep deprivation Friday 530 am through Saturday 800 pm 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 1100 pm 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 eg 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 1100 pm While awake they could engage in quiet activities in the laboratory eg reading watching TV using the computer but were not allowed to sleep or stay in the bedroom during the day They could attend a 15-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
Treatments
The 21-hour treatment period was scheduled from 1100 pm on Friday to 800 pm on Saturday Subjects in both the intensive sleep retraining and total sleep deprivation groups experienced at least 385 hours of sleep deprivation Friday 530 am through Saturday 800 pm 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 1100 pm 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 eg 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 1100 pm While awake they could engage in quiet activities in the laboratory eg reading watching TV using the computer but were not allowed to sleep or stay in the bedroom during the day They could attend a 15-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None