Trial Outcomes & Findings for Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea (NCT NCT04643782)
NCT ID: NCT04643782
Last Updated: 2023-02-14
Results Overview
The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives.
COMPLETED
NA
287 participants
1 night
2023-02-14
Participant Flow
Participant milestones
| Measure |
ANNE Sleep System
After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
ANNE Sleep: ANNE sleep system
|
|---|---|
|
Overall Study
STARTED
|
287
|
|
Overall Study
COMPLETED
|
225
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=225 Participants
After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
ANNE Sleep: ANNE sleep system
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
225 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 nightThe diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives.
Outcome measures
| Measure |
Single Arm Study
n=225 Participants
After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
ANNE Sleep: ANNE sleep system
|
|---|---|
|
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
Sensitivity
|
89.7 percentage of true cases
Interval 79.9 to 95.8
|
|
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
Specificity
|
97.5 percentage of true cases
Interval 93.6 to 99.3
|
Adverse Events
Single Arm Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place