Trial Outcomes & Findings for Brain Energy Metabolism and Sleep in Adults (NCT NCT03929302)
NCT ID: NCT03929302
Last Updated: 2024-06-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Pre and within 2 weeks post myTAP Mouth Shield intervention
Results posted on
2024-06-20
Participant Flow
248 participants were screened for eligibility criteria, of which 41 consented by signing the informed consent to participate in the study in three arms: cognitively normal, mild cognitive impairment, and Alzheimer's disease.
Participant milestones
| Measure |
Cognitively Normal Adults Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Mild Cognitive Impairment (MCI) Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Alzheimer's Disease Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
|---|---|---|---|
|
Neurocognitive and MRS Testing
STARTED
|
15
|
15
|
11
|
|
Neurocognitive and MRS Testing
COMPLETED
|
15
|
15
|
11
|
|
Neurocognitive and MRS Testing
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention - myTAP Mouth Shield
STARTED
|
15
|
15
|
11
|
|
Intervention - myTAP Mouth Shield
COMPLETED
|
7
|
7
|
6
|
|
Intervention - myTAP Mouth Shield
NOT COMPLETED
|
8
|
8
|
5
|
Reasons for withdrawal
| Measure |
Cognitively Normal Adults Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Mild Cognitive Impairment (MCI) Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Alzheimer's Disease Group
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
|---|---|---|---|
|
Intervention - myTAP Mouth Shield
Withdrawal by Subject
|
5
|
8
|
4
|
|
Intervention - myTAP Mouth Shield
Time constraints
|
3
|
0
|
0
|
|
Intervention - myTAP Mouth Shield
Device didnot fit
|
0
|
0
|
1
|
Baseline Characteristics
Brain Energy Metabolism and Sleep in Adults
Baseline characteristics by cohort
| Measure |
Cognitively Normal Adults Group
n=15 Participants
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Mild Cognitive Impairment Group
n=15 Participants
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Alzheimer's Disease Group
n=11 Participants
Part A-The basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance will be explored.
Part B- A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.47 years
STANDARD_DEVIATION 6.13 • n=99 Participants
|
66.53 years
STANDARD_DEVIATION 6.74 • n=107 Participants
|
71.73 years
STANDARD_DEVIATION 5.68 • n=206 Participants
|
67.24 years
STANDARD_DEVIATION 5.23 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
11 participants
n=206 Participants
|
41 participants
n=7 Participants
|
|
Education
|
17.83 years
STANDARD_DEVIATION 2.91 • n=99 Participants
|
17.33 years
STANDARD_DEVIATION 3.21 • n=107 Participants
|
16.82 years
STANDARD_DEVIATION 3.68 • n=206 Participants
|
17.46 years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
PRIMARY outcome
Timeframe: Pre and within 2 weeks post myTAP Mouth Shield interventionPopulation: 41 participants consented of which 18 participants completed the study.
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.
Outcome measures
| Measure |
Cognitively Normal Adults Group
n=7 Participants
A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Mild Cognitive Impairment Group
n=7 Participants
A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
Alzheimer's Disease Group
n=6 Participants
A sample of the group will be included to investigate whether MyTAP oral airway management with a mouth shield improves sleep and cognition.
|
|---|---|---|---|
|
Change From Baseline: Memory Cognitive Domain Assessed by Montreal Cognitive Test (MoCA)
|
28.60 score on a scale
Standard Deviation 1.52
|
26.4 score on a scale
Standard Deviation 1.52
|
20.6 score on a scale
Standard Deviation 1.95
|
Adverse Events
Brain Energy Metabolism and Sleep on Cognition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
myTAP Mouth Shield - Intervention to Improve Sleep and Cognition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place