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NCT Number: NCT04024787

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perform Center, Concordia University

Montreal, Quebec, H4B 1R6, Canada

About this study

Study hypothesis

Brain responses associated with working memory task and declarative memory encoding will be decreased in chronic insomnia compared to good sleepers and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger recovery in these brain responses, compared to a 3-month wait period.

Brain responses to emotional stimulation, especially to insomnia-related stimuli, will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in these brain responses, compared to a 3-month wait period.

Connectivity in the default-mode and limbic networks during resting-state will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in this connectivity, compared to a 3-month wait period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Sleep apnea with an apnea-hypopnea index > 5/h
  • Restless legs syndrome with symptoms 3 days or more per week
  • Periodic limb movements during sleep with index > 15/h
  • REM-sleep behavior disorder
  • Narcolepsy and other central disorders of hypersomnolence
  • Sleepwalking more than once/month
  • Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months or expecting to do so during the study period
  • Severe mental disorders: bipolar disorder (Type I), schizophrenia, anxiety disorders, major depressive disorder, current substance use disorder, current post-traumatic stress disorder
  • Current suicidality
  • Frequent alcohol consumption (>10 glasses/week) or use of cannabis (more than once a week) or illicit drugs (more than once a month)
  • Smoking cigarettes more than 10 cigarettes/day
  • Pregnant or breastfeeding women
  • Current psychotherapy or past cognitive-behavioural therapy for insomnia
  • Current use of medication for depression or anxiety
  • Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment
  • For good sleepers: insomnia symptoms more than 3 times/ week.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3 months

    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.

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

    Time frame: 3 months

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

    Time frame: 3 months

    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.

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

    Time frame: 3 months

    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.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 3 months and 1 year

    Self-reported insomnia severity

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months and 1 year

    Self-reported sleep quality

  3. Total sleep time

    Time frame: 3 months and 1 year

    Self-reported total sleep time from 14-day sleep diary

  4. Total sleep time

    Time frame: 3 months

    Total sleep time from 14-day actigraphy

  5. Sleep latency

    Time frame: 3 months and 1 year

    Self-reported sleep latency from 14-day sleep diary

  6. Sleep latency

    Time frame: 3 months

    Sleep latency from 14-day actigraphy

  7. Wake-after-sleep-onset (WASO)

    Time frame: 3 months and 1 year

    Self-reported duration of wake-after-sleep-onset from 14-day sleep diary

  8. Wake-after-sleep-onset (WASO)

    Time frame: 3 months

    Duration of wake-after-sleep-onset from 14-day actigraphy

  9. Sleep efficiency

    Time frame: 3 months and 1 year

    Self-reported sleep efficiency from 14-day sleep diary

  10. Sleep efficiency

    Time frame: 3 months

    Sleep efficiency from 14-day actigraphy

  11. Diagnosis of insomnia disorder

    Time frame: 3 months and 1 year

    A trained interviewer evaluates the presence of an insomnia disorder using the SCID-V

  12. PSG total sleep time

    Time frame: 3 months

    Total sleep time from overnight polysomnography

  13. PSG sleep latency

    Time frame: 3 months

    Sleep latency from overnight polysomnography

  14. PSG wake-after-sleep-onset (WASO)

    Time frame: 3 months

    Duration of wake-after-sleep-onset from overnight polysomnography

  15. PSG sleep efficiency

    Time frame: 3 months

    Sleep efficiency from overnight polysomnography

  16. Sleep stage durations (N1, N2, N3, REM)

    Time frame: 3 months

    Durations of each sleep stage from overnight polysomnography

  17. Arousal index

    Time frame: 3 months

    Number of EEG arousals per hour from overnight polysomnography

  18. Spindle density

    Time frame: 3 months

    Number of sleep spindles per minute of stage N2-N3 sleep from overnight polysomnography

  19. Dim light melatonin onset (DLMO)

    Time frame: 3 months

    Objective measure of central circadian timing (dim light melatonin onset; DLMO) will be obtained from hourly evening saliva samples

  20. Cortisol

    Time frame: 3 months

    Cortisol will be assessed using salivary samples collected at bedtime, awakening and 45 minutes after awakening

  21. Heart rate variability

    Time frame: 3 months

    Heart rate variability will be measured using the electrocardiogram leads during the overnight assessments

  22. Blood pressure

    Time frame: 3 months

    Blood pressure is assessed using an oscillometer measurement of systolic and diastolic blood pressure in the morning following the overnight assessments

  23. Circulating interleukin-6

    Time frame: 3 months

    Markers will be quantified using blood sample during the overnight assessments

  24. Circulating tumor necrosis factor-alpha

    Time frame: 3 months

    Markers will be quantified using blood sample during the overnight assessments

  25. Circulating C-reactive protein

    Time frame: 3 months

    Markers will be quantified using blood sample during the overnight assessments

  26. Circulating neurotrophic factor BDNF

    Time frame: 3 months

    Markers will be quantified using blood sample during the overnight assessments

  27. Beck Depression Inventory (BDI)

    Time frame: 3 months and 1 year

  28. State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

    Time frame: 3 months and 1 year

  29. Sahlgrenska Academy Self-reported Cognitive Impairment Questionnaire (SASCI-Q, adapted version)

    Time frame: 3 months and 1 year

    Questionnaire assessing self-reported (subjective) memory complaints. Total score ranges from 29 to 203 (higher score reflects more self-reported cognitive complaints).

  30. Work and Social Adjustment Scale (WSAS)

    Time frame: 3 months and 1 year

    Self-reported measure assessing perceived functional impairment associated with insomnia. Total score ranges from 0 to 40 (lower score reflects less impairment).

  31. The Implicit Positive and Negative Affect Test (IPANAT)

    Time frame: 3 months and 1 year

  32. Beliefs and Attitudes about Sleep (DBAS)

    Time frame: 3 months and 1 year

  33. Daytime Insomnia Symptom Response Scale (DISRS)

    Time frame: 3 months and 1 year

    Self-report measures assessing sleep-related rumination

  34. Attention

    Time frame: 3 months

    Attention will be assessed using computerized divided attention and multitasking tasks assessed in the evening and morning of the overnight assessments

  35. Gray matter volume (GMV)

    Time frame: 3 months

    Brain morphometric measure from MRI

  36. Cortical thickness

    Time frame: 3 months

    Brain morphometric measure from MRI

  37. White matter integrity (fractional anisotropy, mean diffusivity)

    Time frame: 3 months

    Brain measure from MRI

  38. GABA

    Time frame: 3 months

    GABA concentration from Magnetic Resonance Spectroscopy (in the anterior cingulate cortex)

  39. Trier Inventory for Chronic Stress - short form

    Time frame: 3 months and 1 year

  40. Subjective happiness scale

    Time frame: 3 months and 1 year

    Self-reported measure of global subjective happiness. Total score ranges from 4 to 28 (higher score reflects greater happiness).

  41. Temporal experience of pleasure scale (adapted version)

    Time frame: 3 months and 1 year

    Self-reported measure of anticipatory and consummatory facets of pleasure. Total score ranges from 18 to 52 (higher score reflects greater pleasure).

  42. Fatigue symptom inventory

    Time frame: 3 months and 1 year

  43. Positive and Negative Affect Schedule

    Time frame: 3 months and 1 year

  44. Munich Chronotype Questionnaire (MCTQ)

    Time frame: 3 months and 1 year

    Questionnaire on self-reported sleep habits, assessing individual chronotype (e.g., early type, normal type late type).

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Neural Responses and Connectivity During Rest, Memory Encoding and Emotional Stimulation in Chronic Insomnia, and Their Relationships With Insomnia Treatment: a Wait-list Controlled Randomized Trial of Cognitive-behavioural Therapy for Insomnia

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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