Brain Energy Metabolism and Sleep in Adults

Summary

The three primary goals of this pilot will be followed by a secondary goal to test if dental intervention improves brain health in terms of sleep and cognition. The primary and secondary goals are

1. Explore the ratios of brain energy (ATP/PCr, Pi/PCr) and phospholipids (PME/PDE) metabolites as measured by magnetic resonance spectroscopy at 7 Tesla, and compare the differences in them with the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups: cognitively normal adults, mild cognitive impairment (MCI) and Alzheimer's disease (AD).
2. Investigate the differences in sleep patterns measured by the ratio sleep quality index (Stable/ Unstable sleep) in cognitively normal adults, MCI and AD and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups.
3. Investigate the differences in the variations of two genes, APOE-E4 and ABCA7, in relationship to the changes in the brain energy metabolites and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in those with cognitively normal adults, MCI and AD.
4. Investigate if dental intervention improves sleep patterns and overall cognitive behavior in the three cohorts.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Cognitive Change
• Energy Metabolism
• Sleep Disturbance

Interventions

DEVICE

MyTAP oral appliance plus mouth shield

The midline traction oral appliance (MyTAP, AMI Inc., Dallas, Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared will be used in all the three arms.

Sponsors & Collaborators

• Texas A & M University Baylor College Of Dentistry

  collaborator OTHER

• University of Texas, Southwestern Medical Center at Dallas

  collaborator OTHER

• The University of Texas at Dallas

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-30

Primary Completion

2020-01-31

Completion

2020-01-31

FDA Device

Yes

Countries

• United States

Study Locations