Sleep Disorders Trial, Recruiting NCT04632628 Sponsor: University of South Florida Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT04632628
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:

For caregivers:

  • People aged 18 or older
  • People who care for someone with dementia and live with that person
  • People who are willing to be randomly assigned to a treatment group
  • People who can read and understand English
  • People who have been diagnosed with insomnia
  • People who are not currently taking any prescribed or over-the-counter sleep medications, or who have been on a stable dose for at least 6 weeks
  • People whose sleep problems have been ongoing for 6 months or more
  • People who have a reasonable opportunity and environment for sleep but still struggle
  • People experiencing one or more of the following: difficulty falling asleep, difficulty staying asleep, or waking up too early
  • People whose insomnia affects their daytime functioning, such as mood, thinking, social life, or work
  • People whose insomnia screening score meets the required threshold (confirm with trial site)
  • People whose sleep diary records show taking more than 30 minutes to fall asleep, or being awake for more than 30 minutes during the night, on at least 3 nights

For people with dementia:

  • People aged 18 or older
  • People with dementia who live with their caregiver
  • People whose caregiver meets the eligibility criteria for the trial
  • People who are willing to be randomly assigned to a treatment group

Who may not be able to join:

For caregivers:

  • People who are unable to give informed consent
  • People with signs of cognitive impairment based on specific screening tests (confirm with trial site)
  • People with a sleep disorder other than insomnia, such as sleep apnea above a certain severity level
  • People with bipolar disorder or a seizure disorder
  • People with major mental health conditions beyond depression or anxiety, such as psychosis or active thoughts of self-harm
  • People with severe, untreated mental health conditions
  • People taking medications that affect sleep, including certain psychiatric medications or blood pressure medications such as beta-blockers
  • People already receiving non-medication-based treatment for sleep or mood outside of this trial

For people with dementia:

  • People with dementia, or their legal representative, who are unable to give informed consent

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 26 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

Principal Investigator: Christina McCrae, University of Missouri-Columbia

Phone: 573-882-0982

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
University of South Florida
Registry
ClinicalTrials.gov
Start date
14 November 2023
Est. completion
30 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency; Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset; Daily Electronic Sleep and Pain Diaries - Total Sleep Time; Daily Electronic Sleep and Pain Diaries - Sleep Efficiency; Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness; Daily Electronic Sleep and Pain Diaries - Medication Consumption; Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency; Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset; Objective Daily Sleep Actiwatch-2 - Total Sleep Time; Objective Daily Sleep Actiwat...

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: 26 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