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The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SleepFlex Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SleepFlex | Device | SleepFlex Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Freedom From SleepFlex-related Serious Adverse Events | Number of participants with absence of serious adverse events related to the SleepFlex system. | 12 weeks |
| Change in the Apnea-hypopnea Index (AHI) | Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia | Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Supine AHI | Change in the supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The supine position is defined by sleeping on one's back. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Sleep Medicine | Los Angeles | California | 90048 | United States |
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medical office
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| ID | Title | Description |
|---|---|---|
| FG000 | SleepFlex Treatment | SleepFlex: SleepFlex Program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SleepFlex Treatment | SleepFlex: SleepFlex Program |
| 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 | Number of Participants With Freedom From SleepFlex-related Serious Adverse Events | Number of participants with absence of serious adverse events related to the SleepFlex system. | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 weeks
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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 | SleepFlex Treatment | SleepFlex: SleepFlex Program | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Kezirian | Berendo Scientific, LLC | 4152358706 | eric.kezirian@gmail.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 | Jun 15, 2023 | Jun 15, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Change in Non-supine AHI | Change in the non-supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The non-supine position is defined by sleeping in body positions other than one's back. Body position information is collected by the home sleep apnea test, and position-specific information is calculated. | 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| apnea-hypopnea index | The apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. It was measured on a pre-treatment home sleep apnea test performed after study enrollment. | Mean | Standard Deviation | events/hour |
|
|
| Primary | Change in the Apnea-hypopnea Index (AHI) | Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. | Posted | Mean | Standard Deviation | events/hour | 12 weeks |
|
|
|
| Secondary | Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia | Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Change in Supine AHI | Change in the supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The supine position is defined by sleeping on one's back. | Participants who completed study | Posted | Mean | Standard Deviation | events/hour | 12 weeks |
|
|
|
| Other Pre-specified | Change in Non-supine AHI | Change in the non-supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The non-supine position is defined by sleeping in body positions other than one's back. Body position information is collected by the home sleep apnea test, and position-specific information is calculated. | Posted | Mean | Standard Deviation | events/hour | 12 weeks |
|
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|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |