Trial Outcomes & Findings for Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx (NCT NCT03986671)
NCT ID: NCT03986671
Last Updated: 2022-06-21
Results Overview
Proof of diagnostic consistency using both the TM-EMG sensor and NEMG in neuromuscular disorders of the oropharyngeal muscles. Significant Inter rater reliability between two blinded neuromuscular experts when using TM-EMG in the palatoglossal and genioglossus.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
1 hour
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
Normal Subjects
A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI \< 2.
|
Amyotrophic Lateral Sclerosis
Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
|
Obstructive Sleep Apnea (OSA)
Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
9
|
5
|
|
Overall Study
Passed a Screening Visit With ENT
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
30
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Normal Subjects
n=6 Participants
A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI \< 2.
|
Amyotrophic Lateral Sclerosis
n=5 Participants
Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
|
Obstructive Sleep Apnea (OSA)
n=5 Participants
Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=16 Participants
|
|
Age, Continuous
|
23.66 years
STANDARD_DEVIATION 3.90 • n=6 Participants
|
59.20 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
53.20 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
45.47 years
STANDARD_DEVIATION 18.18 • n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
5 participants
n=5 Participants
|
16 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 1 hourProof of diagnostic consistency using both the TM-EMG sensor and NEMG in neuromuscular disorders of the oropharyngeal muscles. Significant Inter rater reliability between two blinded neuromuscular experts when using TM-EMG in the palatoglossal and genioglossus.
Outcome measures
| Measure |
Normal Subjects
n=6 Participants
A group of subjects that have been confirmed to have normal oropharyngeal anatomy by an ENT, and also had an overnight in lab PSG with an AHI \< 2.
|
Amyotrophic Lateral Sclerosis
n=5 Participants
Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
|
Obstructive Sleep Apnea (OSA)
n=5 Participants
Subjects with a confirmed diagnosis of moderate to severe OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher.
|
|---|---|---|---|
|
Proof of Diagnostic Consistency
|
95.7 % agreement
|
78.1 % agreement
|
90 % agreement
|
Adverse Events
Normal Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amyotrophic Lateral Sclerosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obstructive Sleep Apnea (OSA)
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