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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 : April 26, 2019
Sponsor:
Collaborators:
Texas A & M University Baylor College Of Dentistry
University of Texas, Southwestern Medical Center at Dallas
Information provided by (Responsible Party):
Sandra Chapman, PhD, The University of Texas at Dallas

Brief 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.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Eligible participants will be:

  • Ages 55-85 years
  • At least 12 years of education
  • Right hand dominant
  • With or without minor memory complaints (those with a diagnosis of Alzheimer's disease,
  • Participants who can safely have an MRS scan
  • Have motor abilities including the use of the right arm and hand for neuropsychological testing.
  • Able to speak, read, and comprehend English fluently
  • Non-pregnant, and not on Hormone replacement therapy

Exclusion criteria will be:

  • Pregnancy
  • Use of Hormone Replacement therapy
  • Less than 12 years of education
  • Left hand dominant
  • Unable to speak, read and write English fluently (Testing and training material are validated in English).
  • Neurological Disorders, e.g., stroke, brain tumor, cerebral hemorrhage.
  • Autoimmune disorders like fibromyalgia, systemic lupus erythematosus (SLE), Multiple sclerosis and rheumatoid arthritis.
  • Metabolic diseases such as diabetes mellitus, thyroid disorders that are not currently managed by a physician
  • Psychiatric disorders such as bipolar disorder, major depressive disorder, pervasive developmental disorder, schizophrenia, anxiety disorder.
  • Current drug or alcohol abuse
  • Head injuries with an Ohio State University TBI Identification (Short Form) score greater than 3.
  • Cancer treated with radiation and/or chemotherapy
  • General anesthesia within the prior six months
  • Uncorrected vision and hearing problems.
  • Active pain requiring treatment
  • BMI ≥35
  • Previously diagnosed sleep disorders
  • Known chronic obstructive pulmonary disease(COPD)
  • Exclusion for imaging criteria (includes the following, or any other concerns by the AIRC staff)

    • Permanent Makeup.
    • Exclusions for metal safety include questionable ferrous implants, bullets, BB's, shrapnel,
    • Medical devices which are unsafe in MRI.
    • Hearing aid that cannot be removed.

Information from the National Library of Medicine

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


Contacts
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Contact: Namrata Das, MD,MPH 9728833266 Namrata.Das@utdallas.edu
Contact: Sandi Chapman, Ph.D 9728833407 schapman@utdallas.edu

Locations
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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   
Sponsors and Collaborators
The University of Texas at Dallas
Texas A & M University Baylor College Of Dentistry
University of Texas, Southwestern Medical Center at Dallas
  Study Documents (Full-Text)

Documents provided by Sandra Chapman, PhD, The University of Texas at Dallas:
Study Protocol  [PDF] September 1, 2018


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Responsible Party: Sandra Chapman, PhD, Founder and Chief Director, Center for BrainHealth® Dee Wyly Distinguished University Professor, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03929302     History of Changes
Other Study ID Numbers: IRB 18-73
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dyssomnias
Sleep Wake Disorders
Parasomnias
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurologic Manifestations
Signs and Symptoms