Sleep Apnea Syndromes Clinical Trial
Official title:
Validation of a Novel Device for Screening Patients With Symptoms of OSA
| NCT number | NCT03157440 |
| Other study ID # | 2016.661 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2017 |
| Est. completion date | March 31, 2018 |
| Verified date | April 2019 |
| Source | Chinese University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA
| Status | Completed |
| Enrollment | 97 |
| Est. completion date | March 31, 2018 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Patients above 18 years old and below 70 years old, both men and women Exclusion Criteria: - Patients requiring oxygen therapy or noninvasive ventilation; - Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy. - Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the concordance of the ring oximetry with PSG as the gold standard | 1 year |
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|---|---|---|---|
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