Obstructive Sleep Apnea of Adult
Conditions
Brief 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
Detailed description
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
Interventions
DEVICEANNE Sleep
ANNE sleep system
Sponsors
Sibel Health Inc.
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥22 years old. 2. 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. 3. Willingness to give written consent and comply with study procedures
Exclusion criteria
1. 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 2. Inability to understand instructions 3. Has a skin abnormality that precludes assessment 4. Has a history of dementia 5. Patients with implanted pacemakers or defibrillators 6. Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | 1 night | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
ANNE Sleep: ANNE sleep system | 225 |
| Total | 225 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 164 Participants |
| Region of Enrollment United States | 225 Participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 225 |
| other Total, other adverse events | 0 / 225 |
| serious Total, serious adverse events | 0 / 225 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm Study | Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | Sensitivity | 89.7 percentage of true cases |
| Single Arm Study | Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | Specificity | 97.5 percentage of true cases |