Sleep Disorders Trial, Recruiting NCT07036705 Sponsor: University of California, San Francisco Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07036705
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:

  • People aged 18 years or older
  • People who speak English
  • People who are willing to use birth control during the trial, if they were assigned female sex at birth
  • People who are willing to receive text messages from the study team during the trial
  • People who have access to a standard wall power outlet where a sauna blanket can be plugged in
  • People who are able to lie inside a sauna blanket for 15 minutes
  • People whose body size fits within the sauna blanket
  • People who have daily access to the internet through a computer, smartphone, or tablet
  • People who have notable sleep trouble, as shown by a score of 11 or higher on the Insomnia Severity Index (ISI) at two separate screening check-ins
  • People who have been diagnosed with primary insomnia — specifically, difficulty falling asleep — confirmed through a structured clinical interview

Who may not be able to join:

  • People who work night shifts or rotating shifts
  • People who regularly use heat-based practices such as saunas, hot tubs, or long baths within 4 hours of bedtime, for 10 minutes or more, at least twice a week
  • People who are pregnant or planning to become pregnant during the trial period
  • People who plan to travel internationally during the screening period, around the time of the post-treatment assessment, or during the follow-up period (approximately 1 week)
  • People who have another diagnosed or suspected sleep disorder
  • People who have a medical condition that may make using an infrared sauna blanket risky (confirm with trial site)
  • People who take medications that may make using an infrared sauna blanket risky (confirm with trial site)
  • People who have a mental health condition that may better explain their sleep problems, needs to be treated first, or could be made worse by restricting time in bed (confirm with trial site)
  • People who have a medical condition that may better explain their sleep problems, needs to be treated first, or could be made worse by restricting time in bed (confirm with trial site)
  • People who have ever been diagnosed with bipolar disorder, psychosis, or a related psychotic disorder
  • People who have had a major depressive episode in the past 3 months
  • People who, in the past 12 months, have experienced suicidal thoughts or have been diagnosed with alcohol use disorder, most substance use disorders, panic disorder, agoraphobia, social anxiety disorder, OCD, ADHD, PTSD, or an eating disorder
  • People taking mental health medications (such as antidepressants) who have not been on a stable dose for at least the past 8 weeks
  • People who are currently receiving Cognitive Behavioural Therapy for Insomnia (CBT-I)

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 22 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: Ashley E Mason, PhD, University of California, San Francisco

Phone: 415-514-8445

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
Registry
ClinicalTrials.gov
Start date
29 September 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Intervention Acceptability

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: 22 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