Sleep Disorders Trial, Recruiting NCT05963607 Sponsor: VA Office of Research and Development Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05963607
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 who are enrolled in VA (Veterans Affairs) healthcare
  • People of any gender aged 18 or older
  • People who have been diagnosed with long-term (at least 6 months) non-cancer muscle or joint pain, recorded at two or more medical appointments, and who rate their pain at 3 or higher on a scale of 0–10 over the past week
  • People who are experiencing sleep problems, shown by a score of 11 or higher on a standard sleep questionnaire called the ISI

Who may not be able to join:

  • People who have a serious or untreated mental illness (such as psychosis — note that PTSD alone does not exclude someone)
  • People experiencing significant life instability, such as homelessness
  • People who have had thoughts of harming themselves or others, or have made a prior attempt, within the past 3 years (as assessed through a standard interview called the MINI)
  • People for whom a review of their medical records or a standard questionnaire (COMM) shows signs of opioid misuse or opioid use disorder
  • People with major medical conditions or physical reasons that would make it unsafe to lift or use a 15-pound weighted blanket — including current pregnancy, spinal cord injury, or being unable to safely lift 15 pounds
  • People who experience claustrophobia
  • People who have untreated obstructive sleep apnea, or who score in the "high risk" category on a sleep apnea screening tool called STOP-BANG
  • People who are currently using a special blanket, such as a weighted or cooling blanket
  • People currently receiving mental health or pain treatment where that treatment (therapy or medications) has changed in the 3 months before enrolling, or where changes are expected during the 2-month trial period (confirm with trial site)

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 8 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: Irina Strigo, PhD, San Francisco VA Medical Center, San Francisco, CA

Phone: (415) 221-4810

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
1 August 2024
Est. completion
1 April 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pain impact change; Sleep disturbance change

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: 8 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