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This is a pilot study to examine the diagnostic utility of a novel transmembrane surface sensor, and compare signals obtained with the transmembrane sensor to conventional needle EMG signals from healthy volunteers to those with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy) and to those with severe OSA.
Transmembrane electromyography (TM-EMG) may be a feasible and valid non-invasive EMG technique for detecting neuromuscular (NM) impairment. This study will assess whether, in healthy volunteers and participants with known obstructive sleep apnea (OSA) and other NM diseases involving the oropharynx, the same characteristic motor unit potentials obtained on conventional needle EMG (NEMG) can be obtained using a TM-EMG sensor. The purpose of this study is to demonstrate whether the TM-EMG sensor can provide the same diagnostic accuracy as the concentric needle electrode for the diagnosis of NM diseases. Having demonstrated diagnostic similarity of TM-EMG to NEMG, the secondary aim of this study is to confirm that NM disturbance of oropharyngeal striated muscles in participants with OSA can be elicited with the TM-EMG sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG Testing | Experimental | Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmenbrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transmembrane EMG Oropharynx Probe | Device | Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmembrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G). |
| Measure | Description | Time Frame |
|---|---|---|
| Proof of Diagnostic Consistency | 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. | 1 hour |
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Inclusion Criteria:
A cohort of participants with documented neurological disorders involving upper airway striated muscles including ALS and muscular dystrophy with the presence of bulbar symptoms.
A cohort of participants diagnosed with moderate to severe OSA proven by an in-lab PSG, including the following criteria:
A cohort of healthy participants that meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry Mansfield, MD | Perry Mansfield MD Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SENTA Clinic | San Diego | California | 92108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Amyotrophic Lateral Sclerosis | Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement. |
| FG002 | Obstructive Sleep Apnea (OSA) | Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Amyotrophic Lateral Sclerosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proof of Diagnostic Consistency | 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. | Posted | Number | % agreement | 1 hour |
|
2 weeks
Same Definition as clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Studer | Powell Mansfield Inc. | 6198101000 | cstuder@powellmansfield.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2019 | Apr 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000690 | Amyotrophic Lateral Sclerosis |
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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This is a prospective, cohort, pilot study with blinded data analysis and two physician testers to assess intertester reliability and device usability. Volunteers will include healthy adults, participants with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy), and participants with severe OSA. For each participant diagnostic properties of EMG studies will be assessed using a conventional needle and TM-EMG sensor in pharyngeal muscles.
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|
Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement.
| BG002 | Obstructive Sleep Apnea (OSA) | Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Obstructive Sleep Apnea (OSA) | Subjects with a confirmed diagnosis of moderate to severe OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher. |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Amyotrophic Lateral Sclerosis | Patients having a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) with bulbar involvement. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Obstructive Sleep Apnea (OSA) | Subjects with a confirmed diagnosis of OSA confirmed by in-laboratory polysomnography (PSG) with an AHI of 25 or higher. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|