NCT05421754

ANNE Diagnostic Agreement With Home Sleep Testing

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	ANNE Sleep	ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-04-30
• Completion: 2023-02-28
• First posted: 2022-06-16
• Last updated: 2023-05-26
• Results posted: 2023-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study