Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have normal cognitive function, as measured by a telephone-based memory and thinking test (score of 29 or higher).
• People who have been diagnosed with moderate to severe obstructive sleep apnea (a condition where breathing repeatedly stops during sleep).
• People who are currently receiving treatment for sleep apnea and have been on that treatment for at least 3 months.
• People who consistently use a CPAP machine (a device that helps keep airways open during sleep) for at least 4 hours a night, at least 5 nights a week.
• People who experience significant daytime sleepiness, either based on a sleepiness questionnaire score of 8 or higher, a sleep-related quality-of-life questionnaire, or a complaint raised with their doctor.

Who may not be able to join:

• People who have a documented diagnosis of chronic insomnia or trouble falling asleep, based on a standard insomnia questionnaire.
• People who have a diagnosed disorder affecting their body clock (circadian rhythm disorder).
• People who currently use supplemental (extra) oxygen.
• People who have other sleep-related breathing disorders, such as central sleep apnea, as defined by standard sleep medicine guidelines.
• People who have worked night shifts (regularly between midnight and 6am) in the past 6 months.
• People who have weight-loss (bariatric) surgery scheduled within the next 3 months.
• People who regularly use (more than 2 nights per week) sedatives, stimulants, antipsychotic medications, or other drugs that could affect the accuracy of thinking and memory tests — including regular use of alcohol or marijuana to help with sleep. Melatonin is acceptable.
• People who have had uncontrolled psychiatric illness in the last 6 months, or who have a history of schizophrenia or bipolar disorder. (Some controlled psychiatric conditions may still be eligible — confirm with trial site.)
• People who take methylphenidate (a stimulant medication) for ADHD.
• People who have serious other 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).
• People who regularly use stimulant medications (more than 2 nights per week) and are unable to stop taking them before an MRI scan.
• 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, a loss of consciousness lasting more than 24 hours, or traumatic brain injury. People diagnosed with mild cognitive impairment based on memory testing, or who have experienced delirium in the last 12 months, are also not eligible.
• People who have had a near-miss or actual car accident caused by falling asleep at the wheel within the past 12 months.
• People who work as commercial drivers (such as bus drivers, train engineers, or airline pilots) or construction workers during the study period.
• People who have previously had a bad reaction or sensitivity to transcranial photobiomodulation (tPBM), a type of light-based brain therapy used in this trial.
• People who have significant skin conditions on their scalp — such as certain birthmarks, scarring skin conditions, psoriasis, rashes, open wounds, or tattoos — in the areas where the treatment device would be placed.
• People who have used light-activated medications (used in a treatment called photodynamic therapy) within 14 days before joining the study.
• People who have certain implants in their head that could be affected by the light-based treatment, such as stents, clipped aneurysms, or implanted valve devices.
• People who are unable to safely have an MRI scan, for example due to claustrophobia, non-removable metal piercings, implanted medical devices, or other non-removable metals in the body.

Important: Always verify eligibility with the trial site directly before applying.