An interventional study of ANNE Sleep in Obstructive Sleep Apnea of Adult, sponsored by Northwestern University. Completed at 4 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Northwestern University · Not applicable, Interventional, and Diagnostic
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 287 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
Device: ANNE Sleep
ANNE sleep system
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
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.
Time frame: 1 night
| Milestone | ANNE Sleep System |
|---|---|
| Started | 287 |
| Completed | 225 |
| Not completed | 62 |
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.
| percentage of true cases | Single Arm Study |
|---|---|
| Sensitivity | 89.7 (79.9 to 95.8) |
| Specificity | 97.5 (93.6 to 99.3) |
Collected over One night of sleep.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Study | 0/225 (0%) | 0/225 (0%) | 0/225 (0%) |
| Age, Continuous(years) | Single Arm Study |
|---|---|
| Mean | 52.7 ± 14.0 |
| Sex: Female, Male(Participants) | Single Arm Study |
|---|---|
| Female | 127 |
| Male | 98 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm Study |
|---|---|
| Hispanic or Latino | 19 |
| Not Hispanic or Latino | 202 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Single Arm Study |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 26 |
| White | 164 |
| More than one race | 10 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(Participants) | Single Arm Study |
|---|---|
| United States | 225 |
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Plan to share: No — Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Northwestern University