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Non-Contact Sleep Breathing Events and Heart Disease Detection

Non-Contact Sleep Breathing Events and Heart Disease Detection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090795
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep apnea complicated with cardiovascular diseases

Interventions

Gold Standard:OSA was diagnosed after at least 4 h of continuous overnight PSG or PM monitoring that confirmed an AHI or REI = 15 events/h and more than 50% of the events were obstructive respiratory
Index test:A non-contact sleep apnea monitoring device for ballistocardiogram signal acquisition

Sponsors

Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 20-75 years old, male and female; 2. Meet the diagnostic criteria for potential sleep apnea and are in a clinically stable period; 3. It can get up and sit upright; 4. Get up less than 3 times at night; 5. Obtain the consent of the subject, family member, guardian or legal representative and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Airway obstruction caused by asthma and other non-chronic obstructive pulmonary diseases; 2. Resting heart rate >100 beats/min; 3. Uncontrolled chronic diseases, such as uncontrolled hypertension (resting blood pressure ?160/100mmHg); Uncontrolled diabetes (random blood glucose >16.7 mmol/l, hemoglobin A1C > 7.0%); 4. Advanced tumor or severe disease; 5. Lack of basic motor ability of joint, peripheral vascular and neuropathy; 6. Mental cognitive impairment; 7. Poor compliance; 8. Women who are breastfeeding or pregnant or plan to become pregnant during the study period, or women who are fertile but unable to use effective contraceptive methods; 9. Complicated with severe liver and kidney disease (severe liver disease refers to bleeding from cirrhosis, portal hypertension and varicose veins, severe kidney disease including dialysis and kidney transplantation)

Design outcomes

Primary

MeasureTime frame
Accuracy;Area under ROC curve, AUC;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactJian Dai

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

fjptdj@163.com+86 181 7233 8893

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026