ANNE Diagnostic Agreement With Home Sleep Testing

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Low Burden Wearable Sensor System for Diagnosing Obstructive Sleep Apnea Over Multiple Nights: Diagnostic Agreement With Home Sleep Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421754
• Other study ID #: STU00214445
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ANNE Sleep
ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Sibel Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 nights