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Brain Energy Metabolism and Sleep in Adults

Start: November 30, 2018
End: December 31, 2022
Enrollment: 60

What Is This Study About?

The first phase of this study will investigate the relationship of sleep abnormalities, genes, and brain energy on cognition in people who are cognitively normal, have mild cognitive impairment, or have Alzheimer's disease. The second phase will test the effects of an oral airway management system on sleep and cognition. Participants will complete neurocognitive testing, genetic testing for Alzheimer's risk genes ApoE4 and ABCA7, a sleep assessment, and an MRI scan. For the second phase of the study, participants with abnormal sleep and upper airway obstruction will be invited to use the myTAP device for three months followed by neurocognitive testing and sleep assessment. myTAP is approved by the U.S. Food and Drug Administration for the treatment of snoring and obstructive sleep apnea.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • At least 12 years of education
  • Right-hand dominant
  • With or without minor memory complaints
  • Participants who can safely have a magnetic resonance imaging (MRI) scan
  • Have motor abilities including the use of the right arm and hand for neuropsychological testing
  • Able to speak, read, and comprehend English fluently (testing and training material are validated in English)
  • Non-pregnant and not on hormone replacement therapy

Must NOT have:

  • Neurological disorders (e.g., stroke, brain tumor, or cerebral hemorrhage)
  • Autoimmune disorders such as fibromyalgia, systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis
  • Metabolic diseases such as diabetes mellitus or thyroid disorders that are not currently managed by a physician
  • Psychiatric disorders such as bipolar disorder, major depressive disorder, pervasive developmental disorder, schizophrenia, and anxiety disorder
  • Current drug or alcohol abuse
  • Head injuries that may have resulted in traumatic brain injury
  • Cancer treated with radiation and/or chemotherapy
  • General anesthesia within past six months
  • Uncorrected vision and hearing problems
  • Active pain requiring treatment
  • Body mass index of 35
  • Previously diagnosed sleep disorders
  • Known chronic obstructive pulmonary disease
  • Exclusion criteria for MRI: permanent makeup; metal implants, bullets, or shrapnel; certain medical devices such as a pacemaker; or hearing aid that cannot be removed

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: The University of Texas at Dallas

Collaborator Sponsor

  • Texas A & M University Baylor College of Dentistry
  • University of Texas, Southwestern Medical Center at Dallas

Source: ClinicalTrials.gov ID: NCT03929302