Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
Interventions
DEVICESleepFlex
SleepFlex Program
Sponsors
Berendo Scientific, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 years and older * Mild to moderate OSA, defined as AHI \>10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment * Central or mixed disordered breathing events (≤25% of total number of events) * Unable to tolerate or decline positive airway pressure therapy * Body mass index ≤32 kg/m2 * Able to protrude tongue ≥20 mm beyond maxillary incisors * Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification * No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder * Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score \>10 * No uncontrolled nasal obstruction * Absence of moderate to severe mandibular insufficiency * No previous surgery involving the oral cavity or pharynx other than tonsillectomy * No previous radiation therapy to the head and neck * No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders * No psychiatric diagnoses other than treated depression or mild anxiety * Stable medication regimen for ≥1 month * No acute illness or infection * Ownership of personal smartphone with iOS or Android operating system * No known hypersensitivity to any material of the SleepFlex devices
Exclusion criteria
* Unwilling or unable to provide informed written consent in English * Pregnancy, breastfeeding, or plans to become pregnant * Smoker (tobacco or recreational drugs) in the past month * Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day * Significant vision or hearing problems * Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires * Any other reason the investigator determines as being unfit for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From SleepFlex-related Serious Adverse Events | 12 weeks | Number of participants with absence of serious adverse events related to the SleepFlex system. |
| Change in the Apnea-hypopnea Index (AHI) | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia | 12 weeks | Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Supine AHI | 12 weeks | 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. |
| Change in Non-supine AHI | 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
medical office
Participants by arm
| Arm | Count |
|---|---|
| SleepFlex Treatment SleepFlex: SleepFlex Program | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | SleepFlex Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| apnea-hypopnea index | 15.1 events/hour STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SleepFlex Treatment | Change in the Apnea-hypopnea Index (AHI) | 2.9 events/hour | Standard Deviation 3.5 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SleepFlex Treatment | Number of Participants With Freedom From SleepFlex-related Serious Adverse Events | 10 Participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SleepFlex Treatment | Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia | 0 Participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SleepFlex Treatment | Change in Non-supine AHI | 0.5 events/hour | Standard Deviation 4.6 |
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.
Time frame: 12 weeks
Population: Participants who completed study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SleepFlex Treatment | Change in Supine AHI | 5.7 events/hour | Standard Deviation 6.1 |