Chronic InsomniaNCT04024787
Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks
A study testing Cognitive-Behavioural therapy for insomnia (CBT-I) in people with Chronic Insomnia, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Cognitive-Behavioural therapy for insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2019to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 80 participants with chronic primary insomnia (40 per group) 40 good sleepers
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Insomnia
- Being tested
- Cognitive-Behavioural therapy for insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioural therapy for insomnia (CBT-I)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Not described Receives: Behavioral: Cognitive-Behavioural therapy for insomnia (CBT-I) |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (44)
Insomnia Severity Index (ISI)
Self-reported insomnia severity
Measured: 3 months and 1 year
Pittsburgh Sleep Quality Index (PSQI)
Self-reported sleep quality
Measured: 3 months and 1 year
Total sleep time
Self-reported total sleep time from 14-day sleep diary
Measured: 3 months and 1 year
Total sleep time
Total sleep time from 14-day actigraphy
Measured: 3 months
Sleep latency
Self-reported sleep latency from 14-day sleep diary
Measured: 3 months and 1 year
Sleep latency
Sleep latency from 14-day actigraphy
Measured: 3 months
Wake-after-sleep-onset (WASO)
Self-reported duration of wake-after-sleep-onset from 14-day sleep diary
Measured: 3 months and 1 year
Wake-after-sleep-onset (WASO)
Duration of wake-after-sleep-onset from 14-day actigraphy
Measured: 3 months
Sleep efficiency
Self-reported sleep efficiency from 14-day sleep diary
Measured: 3 months and 1 year
Sleep efficiency
Sleep efficiency from 14-day actigraphy
Measured: 3 months
Diagnosis of insomnia disorder
A trained interviewer evaluates the presence of an insomnia disorder using the SCID-V
Measured: 3 months and 1 year
PSG total sleep time
Total sleep time from overnight polysomnography
Measured: 3 months
PSG sleep latency
Sleep latency from overnight polysomnography
Measured: 3 months
PSG wake-after-sleep-onset (WASO)
Duration of wake-after-sleep-onset from overnight polysomnography
Measured: 3 months
PSG sleep efficiency
Sleep efficiency from overnight polysomnography
Measured: 3 months
Sleep stage durations (N1, N2, N3, REM)
Durations of each sleep stage from overnight polysomnography
Measured: 3 months
Arousal index
Number of EEG arousals per hour from overnight polysomnography
Measured: 3 months
Spindle density
Number of sleep spindles per minute of stage N2-N3 sleep from overnight polysomnography
Measured: 3 months
Dim light melatonin onset (DLMO)
Objective measure of central circadian timing (dim light melatonin onset; DLMO) will be obtained from hourly evening saliva samples
Measured: 3 months
Cortisol
Cortisol will be assessed using salivary samples collected at bedtime, awakening and 45 minutes after awakening
Measured: 3 months
Heart rate variability
Heart rate variability will be measured using the electrocardiogram leads during the overnight assessments
Measured: 3 months
Blood pressure
Blood pressure is assessed using an oscillometer measurement of systolic and diastolic blood pressure in the morning following the overnight assessments
Measured: 3 months
Circulating interleukin-6
Markers will be quantified using blood sample during the overnight assessments
Measured: 3 months
Circulating tumor necrosis factor-alpha
Markers will be quantified using blood sample during the overnight assessments
Measured: 3 months
Circulating C-reactive protein
Markers will be quantified using blood sample during the overnight assessments
Measured: 3 months
Circulating neurotrophic factor BDNF
Markers will be quantified using blood sample during the overnight assessments
Measured: 3 months
Beck Depression Inventory (BDI)
Measured: 3 months and 1 year
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Measured: 3 months and 1 year
Sahlgrenska Academy Self-reported Cognitive Impairment Questionnaire (SASCI-Q, adapted version)
Questionnaire assessing self-reported (subjective) memory complaints. Total score ranges from 29 to 203 (higher score reflects more self-reported cognitive complaints).
Measured: 3 months and 1 year
Work and Social Adjustment Scale (WSAS)
Self-reported measure assessing perceived functional impairment associated with insomnia. Total score ranges from 0 to 40 (lower score reflects less impairment).
Measured: 3 months and 1 year
The Implicit Positive and Negative Affect Test (IPANAT)
Measured: 3 months and 1 year
Beliefs and Attitudes about Sleep (DBAS)
Measured: 3 months and 1 year
Daytime Insomnia Symptom Response Scale (DISRS)
Self-report measures assessing sleep-related rumination
Measured: 3 months and 1 year
Attention
Attention will be assessed using computerized divided attention and multitasking tasks assessed in the evening and morning of the overnight assessments
Measured: 3 months
Gray matter volume (GMV)
Brain morphometric measure from MRI
Measured: 3 months
Cortical thickness
Brain morphometric measure from MRI
Measured: 3 months
White matter integrity (fractional anisotropy, mean diffusivity)
Brain measure from MRI
Measured: 3 months
GABA
GABA concentration from Magnetic Resonance Spectroscopy (in the anterior cingulate cortex)
Measured: 3 months
Trier Inventory for Chronic Stress - short form
Measured: 3 months and 1 year
Subjective happiness scale
Self-reported measure of global subjective happiness. Total score ranges from 4 to 28 (higher score reflects greater happiness).
Measured: 3 months and 1 year
Temporal experience of pleasure scale (adapted version)
Self-reported measure of anticipatory and consummatory facets of pleasure. Total score ranges from 18 to 52 (higher score reflects greater pleasure).
Measured: 3 months and 1 year
Fatigue symptom inventory
Measured: 3 months and 1 year
Positive and Negative Affect Schedule
Measured: 3 months and 1 year
Munich Chronotype Questionnaire (MCTQ)
Questionnaire on self-reported sleep habits, assessing individual chronotype (e.g., early type, normal type late type).
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start30 Jul 2019
- Primary completion30 May 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Thanh Dang-Vu, Concordia University, Montreal
- Investigators
- Thanh Dang-Vu, MD PhD, Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024787
- Sponsor's protocol ID
- 30011416
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No