Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia

NCT06615336 | Completed

• 1 other identifier: 2021-2015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Sleep Retraining; Total Sleep Deprivation; Control Condition

Keywords

chronic insomnia; intensive sleep retraining; total sleep deprivation

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  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

  During the 2-week pre-treatment, the 2-week post-treatment, and the 1-, 2-, and 3-month follow-ups.

Study Arms (3)

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

Interventions

Intensive Sleep retraining BEHAVIORAL

Intensive Sleep Retraining treatment consisted of 42 sleep onset trials over a 21-hour sleep deprivation period

Intensive Sleep retraining

Total Sleep Deprivation BEHAVIORAL

Total Sleep Deprivation treatment consisted of an equivalent 21-hour sleep deprivation period without sleep onset trials

Total Sleep deprivation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre d'étude des troubles du sommeil

Québec, Quebec, G1J 2G3, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 26, 2024
• Study Start: November 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)