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Search / Trial NCT05771844

Home Sleep Therapy for Older Adults With MCI

Launched by BRAIN ELECTROPHYSIOLOGY LABORATORY COMPANY · Mar 6, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Slow Wave Sleep Nrem N3 Sleep

ClinConnect Summary

This clinical trial is looking at a new way to help older adults with mild cognitive impairment (MCI) improve their sleep and memory. Researchers want to see if a device called SleepWISP, which uses a gentle method of brain stimulation during sleep, can help people get deeper sleep and, in turn, improve their memory. They will also study certain biological markers related to Alzheimer’s disease. The trial aims to answer whether this brain stimulation can enhance deep sleep for one night or over several nights and if better sleep can lead to improved memory performance.

To participate, you need to be between 55 and 85 years old if you have MCI, or between 40 and 80 years old if you are a healthy volunteer. Participants will wear a comfortable device during sleep that monitors brain activity, as well as a watch to track daily movement. Blood samples or nasal swabs will also be collected during the study. It’s important to note that some health conditions, like a history of seizures or severe insomnia, may prevent someone from participating. Overall, this trial offers a promising opportunity to explore how sleep therapy might benefit memory in older adults.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • For participant with Amnestic MCI, the inclusion age range is 55-85 years old.
  • For healthy volunteers without MCI, the inclusion age range is 40-80 years old.
  • Exclusion Criteria:
  • History of seizures
  • History of epilepsy
  • History of mod/severe brain injury or trauma (including neurosurgery)
  • History or presence of significant neurological disease such as Parkinson
  • History of Electroconvulsive Therapy (ECT)
  • Presence of severe insomnia
  • Presence of untreated sleep apnea
  • Presence of severe anxiety or depression
  • Medications that may affect the EEG
  • History of stroke
  • Sensitivity or allergy to lidocaine or silver
  • Presence of active suicidal ideation
  • Presence of metal in head or implants or medication infusion device
  • Pregnancy
  • Adverse reaction to TMS

About Brain Electrophysiology Laboratory Company

The Brain Electrophysiology Laboratory Company is a leading clinical trial sponsor specializing in innovative research and development in the field of neuroscience. With a focus on brain electrophysiology, the company employs state-of-the-art techniques to investigate neural mechanisms underlying various neurological conditions. Committed to advancing the understanding of brain function and improving patient outcomes, the company collaborates with academic institutions and healthcare providers to conduct rigorous clinical trials. Their expertise in data analysis and interpretation ensures the generation of high-quality evidence that supports the development of novel therapeutic interventions.

Locations

Winston Salem, North Carolina, United States

Eugene, Oregon, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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