Trial Outcomes & Findings for ANNE Diagnostic Agreement With Home Sleep Testing (NCT NCT05421754)

NCT ID: NCT05421754

Last Updated: 2023-05-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 4 nights
• Results posted on: 2023-05-26

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Technical issue with sensor	1

Baseline Characteristics

ANNE Diagnostic Agreement With Home Sleep Testing

Baseline characteristics by cohort

Measure	ANNE Sleep n=30 Participants 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.
Age, Continuous	48.4 years STANDARD_DEVIATION 15.3 • n=93 Participants
Sex/Gender, Customized Sex · Female	10 Participants n=93 Participants
Sex/Gender, Customized Sex · Male	17 Participants n=93 Participants
Sex/Gender, Customized Sex · Did not answer	3 Participants n=93 Participants
Race/Ethnicity, Customized Race : Asian	8 participants n=93 Participants
Race/Ethnicity, Customized Race : Black or African American	1 participants n=93 Participants
Race/Ethnicity, Customized Race : White	19 participants n=93 Participants
Race/Ethnicity, Customized Race : Did not answer	3 participants n=93 Participants
Race/Ethnicity, Customized Race : Hispanic or Latino	2 participants n=93 Participants
Body Mass Index (BMI)	28.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=93 Participants
Epworth Sleepiness Scale	8 units on a scale n=93 Participants
Hypertension	8 Participants n=93 Participants
Type II Diabetes	2 Participants n=93 Participants
Asthma	2 Participants n=93 Participants
Depression	6 Participants n=93 Participants
Anxiety	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ANNE Sleep n=29 Participants 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.
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 Interval 28.0 to 85.0
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 Interval 42.8 to 94.5

Adverse Events

ANNE Sleep

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shuai Xu

Northwestern University

Phone: 312-695-8106

Email: stevexu@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place