Evaluation of an OSA Risk Screening Smartphone App in a General, Non-Symptomatic Population Sample (ESOSA)
Abstract
:1. Introduction
2. Materials and Methods
2.1. Target Population, Recruitment and Pre-Screening
2.2. Observational Procedure
2.3. OSA Screening Smartphone App
2.4. Reference Measurement
2.5. Evaluation and Follow-Up
2.6. Study Endpoints
- (a)
- number of participants without a study result due to not completing the study, user mistakes, or measurement failures of the PSG measuring device or the Snorefox M measurement were evaluated as a secondary endpoint.
- (b)
- performance of the Snorefox M software application to detect an AHI ≥ 15 on the entirety of all subjects for whom a full night PSG result is provided, including those in which the Snorefox M device did not provide a result, including the latter cases in the denominator for the calculation of the sensitivity and specificity with corresponding confidence intervals.
- (c)
- subgroup analysis for significant differences in the performance endpoints for sex, age, body mass index (BMI), and ethnicity.
2.7. Statistics
3. Results
3.1. Pre-Screening
3.2. Observational Night
3.3. Performance of the Snorefox M Compared to the Reference PSG
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Section 1 Pre-Screening Questions to Assess Inclusion Criteria | |
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Participants answering “no” to one or more of the questions in Section 1 were excluded from the further recruitment process. |
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Section 2 Pre-Screening Questions to Self-Assess OSA-Related Symptoms | |
Pre-screening questions to self-assess OSA-related symptoms |
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In the following situations, how likely are you doze off or fall asleep, in contrast to just feeling tired? Use the following scale to choose the most appropriate number for each situation:
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Physiological Channel |
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6 × EEG (F3/M2, F4/M1, C3/M2, C4/M1, O1/M2, O2/M1) EOG (left/right) EMG Chin (3×) ECG Leg movements (left/right) Respiration (flow, thermistor) Effort (thorax, abdomen) Oxygen saturation SpO2 Heart rate Pulse wave Snoring (contact microphone) Body position |
Diagnosis According to Current Standard (Type II PSG) | |||
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Snorefox M analysis | Positive (OSA) | Positive (OSA) | Negative (no OSA) |
A | B | ||
Negative (no OSA) | C | D | |
Effectiveness Measures | Definition | ||
Sensitivity | |||
Specificity | |||
Positive Predictive Value (PPV) | |||
Negative Predictive Value (NPV) | |||
False Negative Rate | 1-sensitivity | ||
False Positive Rate | 1-specificity |
Mean | Range | |
---|---|---|
Age (years) | 46.5 | 22–75 |
Height (cm) | 172.7 | 149–195 |
Weight (kg) | 83.2 | 45–150 |
BMI (kg/m2) | 27.9 | 18.4–53.1 |
sex | number of subjects | percent (%) |
female | 83 | 55 |
male | 67 | 45 |
of those female | number of subjects | percent (%) |
pre-menopausal | 48 | 58 |
post-menopausal | 27 | 32 |
would not say | 8 | 10 |
ethnicity | number of subjects | percent (%) |
Hispanic | 0 | 0.0 |
American Indian | 0 | 0.0 |
Asian | 3 | 2.0 |
Black | 1 | 0.7 |
Native Hawaiian | 0 | 0.0 |
White | 146 | 97.3 |
Question | Yes | No | % Yes |
---|---|---|---|
witnessed apnea | 46 | 104 | 31 |
snoring | 129 | 21 | 86 |
hypertension | 25 | 125 | 17 |
ESS score | mean 4.3 | range 0–10 |
Number of Subjects | |
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Subjects enrolled | 150 |
Subjects that did not complete the study | 0 |
Snorefox M did not provide a result | 3 |
PSG invalid result (no SpO2 data) | 3 |
Insufficient sleep time according to EEG | 2 |
All Subjects with a Completed Snorefox M Analysis and a PSG Result (n = 142) | (95% CI) |
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True prevalence | 0.24 (0.17, 0.32) |
Sensitivity 1 | 0.91 (0.76, 0.98) |
Specificity 1 | 0.83 (0.75, 0.90) |
Positive predictive value | 0.63 (0.48, 0.77) |
Negative predictive value | 0.97 (0.91, 0.99) |
Subgroup: Sex | Male | Female | |
---|---|---|---|
Total subjects (n) | 64/142 (45%) | 78/142(55%) | p = 0.003 |
True prevalence | 0.36 (0.24, 0.49) | 0.14 (0.07, 0.24) | |
Sensitivity | 0.91 (0.72, 0.99) | 0.91 (0.59, 1.00) | |
Specificity | 0.80 (0.65, 0.91) | 0.85 (0.74, 0.93) | |
PPV | 0.72 (0.53, 0.87) | 0.50 (0.27, 0.73) | |
NPV | 0.94 (0.81, 0.99) | 0.98 (0.91, 1.00) | |
Subgroup: age (split at median) | lower half | upper half | |
Mean (range) | 34.9 (22–48) | 57.6 (49–75) | p < 0.001 |
Total subjects | 71/142 | 71/142 | |
True prevalence | 0.08 (0.03, 0.17) | 0.39 (0.28, 0.52) | |
Sensitivity | 1.00 (0.54, 1.00) | 0.89 (0.72, 0.98) | |
Specificity | 0.88 (0.77, 0.95) | 0.77 (0.61, 0.88) | |
PPV | 0.43 (0.18, 0.71) | 0.71 (0.54, 0.85) | |
NPV | 1.00 (0.94, 1.00) | 0.92 (0.78, 0.98) | |
Subgroup: BMI (split at median) | lower half | upper half | |
Mean (range) | 23.3 (18.4–26.3) | 32.1 (26.4–53.1) | p < 0.001 |
Total subjects (n) | 71/142 | 71/142 | |
True prevalence | 0.10 (0.04, 0.19) | 0.38 (0.27, 0.50) | |
Sensitivity | 0.86 (0.42, 1.00) | 0.93 (0.76, 0.99) | |
Specificity | 0.84 (0.73, 0.92) | 0.82 (0.67, 0.92) | |
PPV | 0.38 (0.15, 0.65) | 0.76 (0.58, 0.89) | |
NPV | 0.98 (0.90, 1.00) | 0.95 (0.82, 0.99) |
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Sommer, J.U.; Lindner, L.; Kent, D.T.; Heiser, C. Evaluation of an OSA Risk Screening Smartphone App in a General, Non-Symptomatic Population Sample (ESOSA). J. Clin. Med. 2024, 13, 4664. https://doi.org/10.3390/jcm13164664
Sommer JU, Lindner L, Kent DT, Heiser C. Evaluation of an OSA Risk Screening Smartphone App in a General, Non-Symptomatic Population Sample (ESOSA). Journal of Clinical Medicine. 2024; 13(16):4664. https://doi.org/10.3390/jcm13164664
Chicago/Turabian StyleSommer, J. Ulrich, Lisa Lindner, David T. Kent, and Clemens Heiser. 2024. "Evaluation of an OSA Risk Screening Smartphone App in a General, Non-Symptomatic Population Sample (ESOSA)" Journal of Clinical Medicine 13, no. 16: 4664. https://doi.org/10.3390/jcm13164664