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Behavioral Intervention
Cognitive Behavioural Therapy for Chronic Insomnia
N/A
Recruiting
Led By Thanh Dang-Vu, MD PhD
Research Sponsored by Concordia University, Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Sleep apnea with an apnea-hypopnea index > 5/h
Arterial bypass or angioplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess whether a psychological treatment for insomnia can help improve daytime functioning by normalizing brain responses to certain tasks.
Who is the study for?
This trial is for adults aged 25-65 with chronic insomnia, experiencing persistent trouble sleeping and daytime issues. It's open to both those suffering from insomnia and good sleepers as controls. Exclusions include serious health conditions like heart failure, untreated thyroid disorders, severe mental disorders, recent major surgery or infections, substance abuse, and certain sleep-related disorders.
What is being tested?
The study tests if Cognitive-Behavioural therapy for insomnia (CBT-I) can normalize brain responses during cognitive tasks and rest in people with chronic insomnia. It aims to improve attentional processing by altering activation in specific brain regions related to memory and emotions.
What are the potential side effects?
Since CBT-I is a psychological treatment involving no medication or invasive procedures, it typically does not have physical side effects. However, participants may experience temporary increases in anxiety or distress while addressing their sleep habits.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have sleep apnea with more than 5 episodes per hour.
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I have had an arterial bypass or angioplasty.
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I have a thyroid condition that hasn't been treated.
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I have not had major surgery in the last 3 months.
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I act out my dreams while sleeping.
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My heart condition limits my daily activities.
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I have had a stroke.
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I experience insomnia symptoms more than three times a week.
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My kidneys do not work well.
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I am either over 65 or under 25 years old.
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I have a current neurological disorder.
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I have chronic pain that affects my sleep.
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I have had a heart attack.
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I have active cancer or was treated for cancer in the last 2 years.
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I experience restless legs syndrome symptoms frequently each week.
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I have had a brain lesion in the past.
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I have been diagnosed with narcolepsy or another sleep disorder.
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I am currently taking medication for depression or anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional magnetic resonance imaging (fMRI) to examine brain responses to declarative memory encoding
Functional magnetic resonance imaging (fMRI) to examine brain responses to insomnia-related stimuli
Functional magnetic resonance imaging (fMRI) to examine brain responses to working memory with increasing task difficulty
+1 moreSecondary study objectives
Arousal index
Attention
Blood pressure
+30 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate interventionExperimental Treatment1 Intervention
Group II: WaitlistActive Control1 Intervention
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Who is running the clinical trial?
Concordia University, MontrealLead Sponsor
28 Previous Clinical Trials
5,101 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,389 Previous Clinical Trials
26,519,324 Total Patients Enrolled
Thanh Dang-Vu, MD PhDPrincipal InvestigatorConcordia University, Montreal
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with chronic primary insomnia.You have worked night shifts or rotating shifts for more than 2 weeks in the last 3 months, or plan to do so during the study.It seems like you provided a fragment of a criterion. Could you please provide more context or clarify the criterion so that I can assist you better?I have sleep apnea with more than 5 episodes per hour.I have had an arterial bypass or angioplasty.I have a thyroid condition that hasn't been treated.I have not had major surgery in the last 3 months.I act out my dreams while sleeping.You have severe mental disorders like bipolar disorder, schizophrenia, anxiety disorders, major depressive disorder, current substance use disorder, or current post-traumatic stress disorder.You drink a lot of alcohol, use cannabis more than once a week, or use illegal drugs more than once a month.My heart condition limits my daily activities.You are currently having thoughts of harming yourself.You smoke more than 10 cigarettes per day.I have had a stroke.I sleepwalk more than once a month.I experience insomnia symptoms more than three times a week.My kidneys do not work well.I am either over 65 or under 25 years old.I have a current neurological disorder.I have not had a severe infection in the last 3 months.You cannot have an MRI scan for medical reasons.You have a pacemaker.I have chronic pain that affects my sleep.I have had a heart attack.I have active cancer or was treated for cancer in the last 2 years.I cannot stop taking my sleep or anxiety medication for 2 weeks before the first check-up.I experience restless legs syndrome symptoms frequently each week.I have had a brain lesion in the past.I am currently in psychotherapy or have had CBT for insomnia.You have frequent leg movements during sleep.I have been diagnosed with narcolepsy or another sleep disorder.I am currently taking medication for depression or anxiety.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate intervention
- Group 2: Waitlist
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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