Obstructive Sleep Apnea of Adult
Conditions
Brief summary
The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).
Detailed description
The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST) for the diagnosis of moderate to severe OSA. Other study objectives include: * Determining diagnostic yield from multiple nights and better usability compared to current HST in the intended population. This will include all subjects and a focus on olders 65 and older. * Gathering participant feedback on the use of the sensors and use of the application elicited through focus groups
Interventions
DEVICEANNE Sleep
ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.
Sponsors
Sibel Health Inc.
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients will use ANNE Sleep system with Home Sleep Testing (HST) during one night followed by three subsequent nights with the ANNE Sleep system alone.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 22 years old. * Subjects with suspected OSA based on history and physical. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible. * Willingness to give written consent and comply with study procedures
Exclusion criteria
-An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection based on the opinion of the investigator, this includes but is not limited to: A. Significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% B. Respiratory muscle weakness due to a neuromuscular condition C. Awake hypoventilation or suspicion of sleep related hypoventilation D. Chronic opioid medication use E. History of stroke F. History of severe insomnia * Inability to understand instructions * Has a skin abnormality that precludes assessment * Has a history of dementia * Patients with implanted pacemakers or defibrillators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. | 4 nights | To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea. |
Countries
United States
Participant flow
Pre-assignment details
Thirty-eight participants consented to the study and thirty participants started the study. Eight participants decided not to participate before any study procedures or were lost to follow-up after the consent process.
Participants by arm
| Arm | Count |
|---|---|
| ANNE Sleep After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone.
ANNE Sleep: ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Technical issue with sensor | 1 |
Baseline characteristics
| Characteristic | ANNE Sleep |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 15.3 |
| Anxiety | 4 Participants |
| Asthma | 2 Participants |
| Body Mass Index (BMI) | 28.2 kg/m^2 STANDARD_DEVIATION 3.9 |
| Depression | 6 Participants |
| Epworth Sleepiness Scale | 8 units on a scale |
| Hypertension | 8 Participants |
| Race/Ethnicity, Customized Race : Asian | 8 participants |
| Race/Ethnicity, Customized Race : Black or African American | 1 participants |
| Race/Ethnicity, Customized Race : Did not answer | 3 participants |
| Race/Ethnicity, Customized Race : Hispanic or Latino | 2 participants |
| Race/Ethnicity, Customized Race : White | 19 participants |
| Sex/Gender, Customized Sex Did not answer | 3 Participants |
| Sex/Gender, Customized Sex Female | 10 Participants |
| Sex/Gender, Customized Sex Male | 17 Participants |
| Type II Diabetes | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea.
To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea.
Time frame: 4 nights
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ANNE Sleep | Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. | Single night | 58 percent agreement |
| ANNE Sleep | Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. | Multiple nights | 75 percent agreement |