Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea

NCT06573372 | Recruiting

• 1 other identifier: 2024 Research 347-001
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea, Obstructive; smart watch; smartphone; Apnea-Hypopnea Index

Outcome Measures

Primary Outcomes (1)

• diagnostic specificity, sensitivity

  The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch

  29/8/2024-31/7/2026

Secondary Outcomes (1)

• apnea-hypopnea index (AHI)

  29/8/2024-31/7/2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suspected OSA patients, scheduled for polysomnography (PSG)

You may qualify if:

• Age ≥ 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed informed consent form.

You may not qualify if:

• Co-morbid or definitively diagnosed other sleep disorders, such as central sleep apnea syndrome, narcolepsy, sleepwalking, and insomnia patients with less than 4 hours of nightly sleep; Severe psychiatric or neurological disorders (such as bipolar disorder, schizophrenia, epilepsy, etc.), currently taking sedatives or antipsychotic drugs, or patients with neurological, epileptic, or other disorders causing involuntary movements; Significant somatic disease affecting sleep that has been definitively diagnosed, such as craniocerebral diseases or injuries, pain from various causes, unstable angina, uncontrolled heart failure, persistent atrial fibrillation, or atrial flutter; or patients with implanted pacemakers; Patients who have undergone CPAP titration or treatment Patients with other severe respiratory diseases causing hypoxemia, such as Obesity hypoventilation, severe chronic obstructive pulmonary disease, severe interstitial lung disease, or thoracic restrictive disease; or patients with respiratory failure from various causes; Pregnant or lactating women; Subjects with skin diseases or injuries around the measurement site or allergic to the materials of the research equipment and control device Subjects with either of the following conditions, resulting in the inability to use watch/bracelet-type wearable devices to collect information on both sides of the upper limbs: bilateral limb disability; abnormal skin on the wrist; severe occlusive vascular disease of the upper limbs; significant edema of the upper limbs; skin covering the wrist, such as tattoos, severe hair that covers the skin Subjects whose compliance is judged to be poor or for other reasons deemed unsuitable for participation in by the investigator

Sponsors & Collaborators

• Peking University First Hospital: lead
• OPPO: collaborator

Study Sites (1)

Cheng Zhang

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: August 27, 2024
• Study Start: August 29, 2024
• Primary Completion: March 26, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)