Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks

NCT04024787 | Active Not Recruiting

• 1 other identifier: 30011416
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of altered daytime functioning that may be associated with cognitive impairments. The neural processes underlying these daytime complaints may involve abnormal activation of brain regions and neural networks involved in working memory, memory encoding and emotions. The goal of this study is to assess whether a psychological treatment for insomnia will reverse these abnormalities in brain responses to cognitive tasks and at rest. A secondary objective of the study is to characterize impairments in attentional processing and assess if the impairments can be reversed by the psychological treatment. We hypothesized that the psychological treatment for insomnia will lead to a normalization of the brain responses to working memory, declarative memory encoding, insomnia-related stimuli, and the functional connectivity within the default-mode and limbic networks.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (4)

• Functional magnetic resonance imaging (fMRI) to examine brain responses to working memory with increasing task difficulty

  Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to working memory in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.

  3 months

• Functional magnetic resonance imaging (fMRI) to examine brain responses to declarative memory encoding

  Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to declarative memory encoding in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.

  3 months

• Functional magnetic resonance imaging (fMRI) to examine brain responses to insomnia-related stimuli

  Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to insomnia-related pictures in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.

  3 months

• Functional magnetic resonance imaging (fMRI) to examine functional connectivity within the default-mode and limbic networks at rest

  Functional magnetic resonance imaging (fMRI) will be used to look at changes in resting state functional connectivity in individuals with chronic insomnia compared to good sleepers, as well as the modifications in this functional connectivity after cognitive-behavioral therapy for insomnia, with a focus on the default-mode and limbic networks.

  3 months

Secondary Outcomes (44)

• Insomnia Severity Index (ISI)

  3 months and 1 year

• Pittsburgh Sleep Quality Index (PSQI)

  3 months and 1 year

• Total sleep time

  3 months and 1 year

• Total sleep time

  3 months

• Sleep latency

  3 months and 1 year

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Behavioral: Cognitive-Behavioural therapy for insomnia (CBT-I)

Waitlist

NO INTERVENTION

Interventions

Cognitive-Behavioural therapy for insomnia (CBT-I) BEHAVIORAL

Participants with chronic primary insomnia are randomized into 2 groups with a 1:1 allocation ratio, after the completion of the pre-treatment assessment. Post-treatment and post-waitlist assessment occur after the 3-month treatment or waiting period. One group will receive the intervention immediately after the pre-treatment assessment and the other group will receive the intervention after a waiting period of 3 months. The intervention consists of manualized cognitive-behavioural therapy for insomnia. This treatment includes psychoeducation about sleep and circadian rhythms, stimulus control, sleep restriction, relaxation, and cognitive therapy. The therapy is administered individually. Participants meet for 8 sessions of 50 minutes spread over 12 weeks.

Immediate intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants with chronic primary insomnia (40 per group) 40 good sleepers

You may not qualify if:

• Older than 65 y.o. or younger than 25 y.o.
• Contraindication to the MRI scanning
• Current neurological disorder
• Past history of brain lesion
• Major surgery (i.e., requiring general anesthesia) in the past 3 months
• Untreated thyroid disorder
• Chronic pain syndrome self-reported as interfering with sleep
• Recent and severe infection in the past 3 months
• Active cancer, or remitted cancer with cancer treatment within the last 2 years
• Stroke
• Myocardial infarct
• Arterial bypass or angioplasty
• Pacemaker
• Heart failure causing limitation of ordinary physical activity
• Renal insufficiency

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Perform Center, Concordia University

Montreal, Quebec, H4B 1R6, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Thanh Dang-Vu, MD PhD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

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: Principal Investigator, Associate Professor

Model Details: This study is a randomized controlled trial. Participants with chronic insomnia are randomized to either immediate cognitive-behavioural therapy or a 3-month wait-list period using a 1:1 allocation ratio. Randomization is conducted with block sizes of 4 participants. Randomization results are contained in sealed opaque envelopes that are opened in the presence of the participants after the completion of the pre-treatment assessment. A second assessment will be conducted after the treatment or waiting period. A follow-up assessment is conducted 12 months after the completion of the post-treatment assessment. A group of good sleepers, matched on age and gender with the insomniacs, will also be recruited and assessed at baseline only to provide a normative reference group.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 18, 2019
• Study Start: July 30, 2019
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)