Sleep Disorders Trial, Recruiting NCT05988385 Sponsor: California Pacific Medical Center Research Institute Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05988385
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 between 55 and 85 years old
  • People whose thinking and memory are considered normal, based on a cognitive screening test score of 29 or higher
  • People who have moderate to severe sleep apnea, confirmed by a sleep test taken within the past 12 months (or confirmed by a repeat test)
  • People who are not currently being treated for sleep apnea, and have not received any sleep apnea treatment for at least 6 months
  • People who are willing and able to receive treatment for sleep apnea as part of the trial
  • People who speak English or Spanish fluently

Who may not be able to join:

  • People who have been diagnosed with chronic insomnia, or who report severe or very severe difficulty falling asleep on a screening questionnaire
  • People who have been diagnosed with a circadian rhythm disorder (a condition where the body's internal clock is significantly disrupted)
  • People who currently use supplemental oxygen
  • People who have another type of sleep-related breathing disorder, such as central sleep apnea
  • People who currently work night shifts (regularly working between 12am and 6am) or have done so in the past 6 months
  • People who have bariatric (weight loss) surgery planned within the next 3 months
  • People who regularly use cannabis to help with sleep more than 2 nights per week
  • People who have an uncontrolled psychiatric condition diagnosed in the last 6 months, or a history of schizophrenia or bipolar disorder (confirm with trial site for details on which conditions may still be considered)
  • People taking methylphenidate (a medication used for ADHD), unless the dose has been stable for some time — the trial's lead doctor would review this on a case-by-case basis
  • People taking certain weight-loss medications (such as Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound) who are also planning to lose 20 pounds or more at the time of joining the trial — the trial's lead doctor would review this individually
  • People with serious ongoing health conditions that would make it difficult to complete the study over 2 years, or that could affect thinking and memory (confirm with trial site for specific conditions)
  • People who do not sleep in the same place most nights (sleeping in a different location more than 2 nights per week)
  • People who are currently pregnant or planning to become pregnant
  • People who have been diagnosed with a brain or nervous system condition such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, traumatic brain injury, or who have experienced a loss of consciousness lasting more than 24 hours — or who have experienced delirium in the past 12 months
  • People who have had a near-miss or actual car accident caused by sleepiness in the past 12 months
  • People who work as commercial drivers (such as bus drivers, train operators, or airline pilots) during the study period
  • People who currently take neuroleptics, benzodiazepines, barbiturates, opiates, or anti-amyloid therapies (certain types of psychiatric, sedative, pain, or dementia-related medications)
  • People taking cognitive-enhancing medications that were started within the last 3 months, or where the dose is not yet stable
  • People who drink more than 14 alcoholic drinks per week, unless their drinking has been reduced and stabilised within the past 3 months

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 15 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: Katie L Stone, PhD, California Pacific Medical Center Research Institute

Phone: 415-633-6229

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
California Pacific Medical Center Research Institute
Registry
ClinicalTrials.gov
Start date
22 April 2024
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in overnight memory retention on the A-B verbal paired associates task; Change in overnight memory retention on the A-B verbal paired associates task; Change in overnight memory retention on the A-B verbal paired associates task; Change in Aβ42/ Aβ40 ratio; Change in Aβ42/ Aβ40 ratio; Change in Plasma P-tau181; Change in Plasma P-tau181; Change in P-tau217; Change in P-tau217; Change in Neurofibrilary light (NfL); Change in Neurofibrilary light (NfL); Preclinical Cognitive Composite Score; Preclinical Cognitive Composite Score; Preclinical Cognitive Composite Score

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: 15 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