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

A comparison of two peripheral arterial tonometry-based sleep devices for the diagnosis of obstructive sleep apnea - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063091

Enrollment

Registered

2024-02-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: G473- Sleep apnea

Interventions

Intervention1: One Sleep test device: The device will be applied on patients finger overnight during sleep study in the hospital on one night(once only, during entire night) Control Intervention1: Lev

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactSaurabh Mittal

All India Institute of Medical Sciences, New Delhi

saurabh_kgmu@yahoo.co.in01126546357

Outcome results

None listed

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