NCT05421754

ANNE Diagnostic Agreement With Home Sleep Testing

Completed NA Results posted Last updated 26 May 2023

What this trial tests

NA trial testing ANNE Sleep in Obstructive Sleep Apnea of Adult in 38 participants. Completed in 28 February 2023.

Timeline

6 January 2022

Primary endpoint
30 April 2022

28 February 2023

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	38
Start date	6 January 2022
Primary completion	30 April 2022
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• ANNE Sleep

Conditions studied

• Obstructive Sleep Apnea of Adult — all drugs for Obstructive Sleep Apnea of Adult →

Sponsor

Northwestern University

Who can join

22 and older, any sex, with Obstructive Sleep Apnea of Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. Primary · 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.

Single night

Group	Value	95% CI
ANNE Sleep	58	28 – 85

Multiple nights

Group	Value	95% CI
ANNE Sleep	75	42.8 – 94.5

Sponsor's own 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments.
   Walter J, Lee JY, Blake S, Kalluri L, et al · · 2023 · cited 5× · PMID 36692166 · DOI 10.5664/jcsm.10432