Brain Energy Metabolism and Sleep in Adults
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|ClinicalTrials.gov Identifier: NCT03929302|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : May 12, 2020
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
- 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).
- 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.
- 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.
- Investigate if dental intervention improves sleep patterns and overall cognitive behavior in the three cohorts.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment Cognitive Change Energy Metabolism Sleep Disturbance||Device: MyTAP oral appliance plus mouth shield||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Brain Energy Metabolism and Sleep in Adults|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||July 31, 2021|
No Intervention: Brain Energy Metabolism and Sleep on cognition
In the phase-1 of the study, the investigator will be investigating the basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance in three cohorts: cognitively normal adults, mild cognitive impairment, and Alzheimer's disease between the age of 55-85 years.
Experimental: Dental Intervention to improve sleep and cognition
To investigate if MyTAP oral airway management with mouth shield will improve sleep and cognition in three cohorts: cognitively healthy adults, mild cognitive impairment, and Alzheimer's disease between the age of 55-85 years.
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 only in Phase-2 of the study. Phase-1 doesn't include any intervention.
- Sleep Improvement with MyTAP oral airway management intervention [ Time Frame: 6 weeks ]Improvement in sleep measured by REM and NREM sleep before and after the interventions.
- Memory cognitive domain improvement after airway management intervention [ Time Frame: 6 weeks ]Improvement in cognitive performance in memory measured using california verbal learning task (CVLT) using paper and pencil task.
- Executive function cognitive domain improvement after airway management intervention [ Time Frame: 6 weeks ]Improvement in cognitive performance in executive function measured using test of strategic learning (TOSL) using paper and pencil task.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929302
|Contact: Namrata Das, MD,MPH||9728833266||Namrata.Das@utdallas.edu|
|Contact: Sandi Chapman, Ph.Dfirstname.lastname@example.org|
|United States, Texas|
|Center for BrainHealth, The university of Texas at Dallas||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Namrata Das, MD,MPH 972-883-3266 Namrata.Das@utdallas.edu|