Sleep Disorders Trial, Recruiting NCT06032377 Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06032377
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 60 years of age or older when you sign up
  • You have sleep problems, based on a sleep questionnaire score of 16 or below, and/or you meet certain standard criteria for insomnia based on your symptoms
  • You have noticed problems with your memory or thinking in everyday life, based on a self-reported questionnaire
  • You can read and understand French or English
  • You are able to use a smartphone or tablet, and you have internet access at home
  • If you currently take any sleep aids, psychiatric medications, or cannabis, your dose has been the same for at least 2 months before joining the study
  • A short questionnaire suggests you are at low risk for obstructive sleep apnea (a breathing problem during sleep)

Who may not be able to join:

  • You live outside of Québec or Ontario
  • You are currently in hospital or have a major surgery planned
  • You have severe hearing or vision problems that have not been corrected
  • You have been told by a doctor that you have a major memory or thinking disorder, or mild cognitive impairment (MCI)
  • A short thinking and memory test suggests you may have a significant cognitive disorder
  • You have been diagnosed with schizophrenia or bipolar disorder, or a screening questionnaire suggests you may have these conditions
  • You are considered to be at high risk of suicide, based on a standard assessment
  • You have another untreated sleep disorder (such as severe sleep apnea, REM sleep behaviour disorder, or restless legs syndrome) — however, if your sleep apnea or restless legs syndrome is being treated and well controlled, you may still be eligible (confirm with trial site)
  • You currently work shift work (irregular or overnight hours)
  • You are currently receiving, or have previously received, Cognitive Behavioural Therapy specifically for insomnia (CBT-I)
  • You drink more than 10 alcoholic drinks per week and this is having a significant impact on your daily functioning
  • You use illegal drugs more than once a month

Additional reasons you may not be able to join the brain scanning (MRI) part of the study:

  • You have taken any sleep aids or psychiatric medications in the past 2 weeks
  • You have a reason you cannot safely have an MRI scan (such as a pacemaker, metal implant, or severe claustrophobia)
  • You are unable or unwilling to travel to one of the MRI centres in Montreal or Ottawa
  • You have a current neurological condition such as epilepsy with a seizure in the past year, a concussion in the past 3 months, multiple sclerosis, or Parkinson's disease
  • You have a history of a brain injury or condition that required brain surgery
  • You have had major surgery requiring general anaesthesia in the past 3 months
  • You have a thyroid disorder that is not being treated
  • You have ongoing chronic pain that you feel is disrupting your sleep (for example, migraines, fibromyalgia, or rheumatoid arthritis)
  • You have had a serious infection in the past 3 months (such as pneumonia or a kidney infection)
  • You currently have cancer, or you finished cancer treatment less than 2 years ago

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +1 (514) 340-3540

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Registry
ClinicalTrials.gov
Start date
15 November 2023
Est. completion
1 May 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Insomnia severity index; Subjective cognitive impairment based on cognitive failure questionnaire; Objective cognitive performance based on a composite score for executive functions from the CANTAB; Geriatric anxiety index; Geriatric depression scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov