Brain Energy Metabolism and Sleep in Adults

NCT03929302 | Terminated Results FDA Device

• 1 other identifier: IRB 18-73
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline: Memory Cognitive Domain Assessed by Montreal Cognitive Test (MoCA)

  To investigate the short-term effects of dental intervention on cognition, especially the memory domain of Montreal Cognitive assessment. The score ranges between 0 and 30. A score between 26 to 30 is considered to be normal. A score between 20 and 25 is for mild cognitive impairment. A score less than 20 is for Alzheimer's disease.

  Pre and within 2 weeks post myTAP Mouth Shield intervention

Study Arms (3)

Cognitively normal adults group

ACTIVE COMPARATOR

A group of cognitively normal adults will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.

Device: MyTAP oral appliance plus mouth shield

Mild Cognitive Impairment (MCI) group

ACTIVE COMPARATOR

A group of MCI will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.

Device: MyTAP oral appliance plus mouth shield

Alzheimer's Disease group

ACTIVE COMPARATOR

A group of AD will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.

Device: MyTAP oral appliance plus mouth shield

Interventions

MyTAP oral appliance plus mouth shield DEVICE

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.

Alzheimer's Disease group; Cognitively normal adults group; Mild Cognitive Impairment (MCI) group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Texas A & M University Baylor College Of Dentistry: collaborator
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Study Sites (1)

Center for BrainHealth, The University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Parasomnias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Sleep Wake Disorders

Limitations and Caveats

As covid situation started in 2019 and into 2020, the study was terminated earlier than anticipated.

Results Point of Contact

• Title: Namrata Das
• Organization: UT Southwestern Medical center

Namrata.Das@utsouthwestern.edu

2146082836

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and Chief Director, Center for BrainHealth® Dee Wyly Distinguished University Professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 26, 2019
• Study Start: November 30, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)