Sleep Disorders Trial, Recruiting NCT03777267 Sponsor: Wake Forest University Health Sciences Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT03777267
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:

  • You are able to follow basic instructions and can sit comfortably while wearing some sensor leads attached to your body.
  • You are experiencing symptoms of stress, anxiety, or sleep problems, and you score at or above a certain level on at least one of the following self-reported questionnaires: the Insomnia Severity Index (score of 8 or more), the Perceived Stress Scale (score of 14 or more), or the Generalized Anxiety Disorder 7-item scale (score of 5 or more).

Who may not be able to join:

  • You are unable or unwilling to give your informed consent to take part in the study.
  • You are not able to travel to the study location or cannot sit comfortably in a chair for up to 1.5 hours.
  • You have severe hearing loss, as the study involves using earbuds.
  • You weigh more than 285 pounds, due to the weight limit of the chair used in the study.
  • You are currently taking part in another active research study that involves an intervention.
  • You have used HIRREM, Brainwave Optimization, Cereset, or a wearable version of these technologies (B2 or B2v2) within the last 3 years.
  • You have previously received electroconvulsive therapy (ECT), which is a type of brain stimulation treatment (confirm with trial site).
  • You have used certain brain stimulation or feedback therapies — including transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) — within the past month.
  • You have a known seizure disorder (epilepsy).

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 5 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: Charles Tegeler, MD, Wake Forest University Health Sciences

Phone: 336-716-9447

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
12 April 2019
Est. completion
1 April 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Heart Rate Variability; Change in Baroreflex Sensitivity; Change in Blood Pressure Variability

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: 5 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