Comparative study of two new devices (based on vessel tone) for the diagnosis of obstructive sleep apnea

Phase 4

Conditions: Health Condition 1: G473- Sleep apnea

Registration Number: CTRI/2024/02/063091

Lead Sponsor: Dr Saurabh Mittal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Study participants should be adults (18 years of age or older)

2. Participants with clinical suspicion of OSA, who are referred for a sleep study

3. Participants should be able to understand and comply with the study procedures and requirements

Exclusion Criteria

1. Participants with a previous diagnosis of obstructive sleep apnea or receiving treatment for the same

2. Participants who are unable or unwilling to provide informed consent

3. Individuals with a history of significant psychiatric disorders or cognitive impairment that may interfere with their ability to participate or comply with the study requirements

4. Pregnant women or individuals who are breastfeeding

5. Patients with known peripheral arterial disease or any other condition that can affect the accuracy of peripheral arterial tonometry measurements

6. Inadequate data acquisition during level 1 polysomnography (less than 120 minutes of sleep time)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the correlation of AHI as measured by One Sleep Test as compared to that by Level-1 polysomnography for the diagnosis of OSATimepoint: At baseline

Secondary Outcome Measures

Name	Time	Method
To assess the correlation between ODI (Oxygen desaturation Index), total sleep time, and sleep efficiency between OST and WatchPAT 200Timepoint: At baseline;To assess the correlation between Time spent below 90% saturation between the two devicesTimepoint: At baseline;To assess the correlation of AHI as measured by One Sleep Test as compared to that by WatchPAT 200 for the diagnosis of OSATimepoint: At baseline;To assess the effect of stiffness index as measured using Artsens device on the correlation of AHI between the three devicesTimepoint: At baseline