Novel Device for Screening Patients With Symptoms of OSA
Validation of a Novel Device for Screening Patients With Symptoms of OSA
1 other identifier
observational
97
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedApril 17, 2019
April 1, 2019
5 months
May 16, 2017
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the concordance of the ring oximetry with PSG as the gold standard
1 year
Interventions
a new type oxymetry wear on index finger like a ring
Eligibility Criteria
patients with symptoms of OSA who will be undergoing sleep study for establishing a diagnosis
You may qualify if:
- Patients above 18 years old and below 70 years old, both men and women
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 17, 2017
Study Start
April 1, 2017
Primary Completion
August 31, 2017
Study Completion
March 31, 2018
Last Updated
April 17, 2019
Record last verified: 2019-04