Sleep Disorders Trial, Recruiting NCT04953559 Sponsor: University of Arizona Condition: Sleep Disorders
Back to Sleep Disorders

Sleep Disorders Trial, Recruiting

NCT04953559
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 men, or women who are not pregnant or breastfeeding, aged 18 to 50 years old, and who are free from certain health conditions, medications, or devices that would prevent participation.
  • People whose sleep trouble meets the criteria for primary insomnia, as shown by scoring above set thresholds on at least two out of three sleep questionnaires (the ISI, PSQI, and ESS) (confirm with trial site).

Who may not be able to join:

  • People who have any metal implants or medical devices in their body that could be unsafe in MRI or brain stimulation procedures — examples include pacemakers, metal stents or clips on blood vessels, artificial heart valves, prosthetic limbs, brain stimulators, implanted drug pumps, ear or eye implants, metal fragments in the eyes, exposure to shrapnel or metal filings, metallic surgical hardware in vital areas, certain tattoos with metallic ink, or certain medicated skin patches (such as nicotine, motion sickness, or birth control patches).
  • People who have a past or current history of sleep or breathing-related disorders, such as sleep apnea, as indicated by a score of 3 or higher on a screening questionnaire called the STOP-BANG.
  • People who have travelled across time zones within the two weeks before joining the study, or who plan to do so at any point during the study.
  • People who report major heart problems, including heart murmur or heart attack, or neurological problems such as traumatic brain injury, stroke, tumour, epilepsy, or other seizure disorders.
  • People who report a past or current history of cardiovascular disease, including irregular heartbeat, heart valve disease, heart failure, sudden cardiac death, or heart attack.
  • People who report a past or current history of a neurological disorder, including brain injury or concussion, stroke, brain tumour, epilepsy or other seizure disorder, amnesia for any reason, fluid on the brain, or multiple sclerosis.
  • People who report any past or current history of seizures or seizure disorders.
  • People who report that a close biological relative (such as a parent or sibling) has a history of seizures or a seizure disorder.
  • People who report a current or ongoing lung condition that requires the use of an inhaler every day.
  • People who report a history of fainting spells or loss of consciousness.
  • People who report a past or current history of psychiatric conditions other than depression or anxiety — including bipolar disorder, mania, ADHD, or psychotic disorders.
  • People who report a history of depression or anxiety disorders within the past two years.
  • People who report thoughts of suicide, as indicated by a score of 2 or higher on a screening questionnaire called the BDI.
  • People who are currently taking certain prescription medications, including sleep medications such as Ambien, benzodiazepines, stimulants, antidepressants, antipsychotics, blood pressure medications, or thyroid medications.
  • People who are currently taking sleep-related supplements such as melatonin, valerian root, or kava root.
  • People who consume more than approximately 300 mg of caffeine per day on average (roughly 3–4 cups of coffee or about 8 cans of caffeinated soft drink).
  • People who regularly use nicotine, defined as more than one cigarette or equivalent per week within the past year.
  • People who drink heavily, defined as 14 or more alcoholic drinks per week.
  • People who use illicit drugs, including but not limited to benzodiazepines, amphetamines, cocaine, or opioids.
  • Women who return a positive pregnancy test at screening.
  • Women who are currently breastfeeding or collecting breast milk.
  • People who did not begin learning English by age 3, or who speak English as a second language.
  • People who have not completed at least a 9th grade level of education.
  • People who have had unusual or irregular sleep schedules in the past six months.
  • People who work overnight shifts.
  • People who are unable to read and sign a consent form.
  • People who are unable or unwilling to meet the requirements of the study.

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

Principal Investigator: William D Killgore, PhD, University of Arizona

Phone: (520) 621-0605

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 Arizona
Registry
ClinicalTrials.gov
Start date
6 August 2021
Est. completion
31 August 2022

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8; Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8; Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15; Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15; Sleep onset latency (SOL) following administration of active or sh...

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