Clinical trial NCT05421754: ANNE Diagnostic Agreement With Home Sleep Testing
Official title: Low Burden Wearable Sensor System for Diagnosing Obstructive Sleep Apnea Over Multiple Nights: Diagnostic Agreement With Home Sleep Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Sibel Health Inc.
First posted: 2022-06-16
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea.
timeFrame: 4 nights
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: