N/A
Completed N=287
Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
Obstructive Sleep Apnea of Adult
Source: ClinicalTrials.gov NCT04643782 ↗
Enrolled (actual)
287
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography — 89.7; 97.5 percentage of true cases
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography |
89.7; 97.5 | — |
Eligibility Criteria
Inclusion Criteria
- ≥22 years old.
- Subjects with suspected OSA based on history and physical who qualify for, and have either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
- Willingness to give written consent and comply with study procedures
Exclusion Criteria
- An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection
- Inability to understand instructions
- Has a skin abnormality that precludes assessment
- Has a history of dementia
- Patients with implanted pacemakers or defibrillators
- Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Data sourced from ClinicalTrials.gov (NCT04643782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.