Obstructive Sleep Apnea Syndrome
Conditions
Interventions
Gold Standard:The gold standard for the diagnosis of obstructive sleep apnea (OSA) is polysomnography (PSG), which mainly collects parameters such as electroencephalogram (EEG), electrooculogram (EOG)
- Awakening from sleep with choking, gasping, or a feeling of suffocation
- Bed partners observe habitual snoring, breathing pauses, or both
- Complicated with hypertension, mood disorders, cognitive impairment, coronary heart disease, stroke, heart failure, atrial fibrillation, or type 2 diabetes.
2. PSG shows:
- 5 or more obstructive-do
Index test:To evaluate the diagnostic accuracy of a novel sleep monitoring device for OSA using PSG as the gold standard
Methods: A multicenter prospective study
Device: DM-AS03 sleep monitoring mattr
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Signed an informed consent form before participating in the study and was able to participate in the study in accordance with the protocol. 2.Patients with specific diseases included those with hypertension, coronary heart disease, stroke, chronic obstructive pulmonary disease (COPD), asthma, etc. 3.Clear consciousness, good communication ability, and able to cooperate with the questionnaire survey.
Exclusion criteria
Exclusion criteria: 1.Patients with severe mental and psychological diseases; 2.Populations who need long-term bed rest or have limited mobility and cannot go to the sleep center; 3.Patients with severe organ failure; 4.Patients with severe diseases, acute infections, or those requiring oxygen therapy; 5.In polysomnography (PSG), the total recorded sleep time is < 240 minutes; 6.Incomplete answers to the scales;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea-Hypopnea Index (AHI);Oxygen Desaturation Index (ODI);Lowest oxygen saturation;Time at SpO? < 90%;Total Sleep Time;Immobility time;Postural events;AUC value under the ROC curve;Sensitivity;Specificity;Positive Predictive Value(PPV);Negative Predictive Value(NPV);Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| neck circumference;waist circumference;hip circumference;Mallampati score;tonsillar hypertrophy;mandibular retrognathia;macroglossia;demographic characteristics;OSA-related clinical symptoms;comorbidities;previous history and treatment of OSA;Epworth Sleepiness Scale;Pittsburgh Sleep Quality Index;Insomnia Severity Index (ISI);Comfort and satisfaction of subjects with different monitoring devices; | — |
Countries
China
Contacts
Public ContactZhang Nuofu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed