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Clinical trial to study the convenience and usability of newly proposed adaptive positive airway pressure mask for obstructive sleep apnea

Breath Assist: A Continuous Positive Airway Pressure System - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066167
Enrollment
100
Registered
2024-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: J962- Acute and chronic respiratory failure

Interventions

Intervention1: Breath assist device: Cordless CPAP device, will be used for mild OSA therapy

Sponsors

Department of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with AHI greater than 5 Subjects complaining of hypersomnia Mild and moderate sleep apnea subjects with increased carbon dioxide level

Exclusion criteria

Exclusion criteria: Severe or chronic respiratory ailment Subjects diagnosed with pneumothorax Subjects with Hypercapnia, Respiratory acidosis

Design outcomes

Primary

MeasureTime frame
reduction in AHI (Apnea Hypopnea Index) of the user, SpO2 will be improved during therapyTimepoint: min 4 to 8 hours of single time usage during night sleep—

Secondary

MeasureTime frame
improved sleep cycle, reduced ODI (oxygen desaturation index), SQI (sleep quality index) will be improved.Timepoint: from 2 weeks of usage.—

Countries

India

Contacts

Public ContactJayanthi T

SRM Institute of Science and Technology

jayantht@srmist.edu.in09840490315

Outcome results

None listed

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