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To compare the effect of fixed pressure versus auto adjusting continuous positive airway pressure treatments in terms of changes in heart rate and blood pressure in patients with Obstructive Sleep Apnoea

Comparison of autonomic function changes by fixed pressure versus auto adjusting continuous positive airway pressure treatments in patients with Obstructive Sleep Apnea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047687
Enrollment
32
Registered
2022-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: AUTO CPAP therapy: AUTO CPAP therapy for 6-8hrs/day, for 4 weeks through nasal or face mask Intervention2: Fixed CPAP/BIPAP therapy: Fixed CPAP/BIPAP therapy for 6-8hrs/day, for 4 week

Sponsors

Dr S Anusha Rao
Lead Sponsor
Dr Abhishek Goyal
Collaborator
Dr Alkesh K Khurana
Collaborator
Dr Ruchi Singh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Treatment naïve and recently diagnosed patients of age eighteen and above with moderate-severe OSA who achieve successful titration with CPAP will be included in this study.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2.History of diabetes mellitus, 3.Coronary artery disease, arrhythmias, Cardiac failure, 4.Presence of other sleep disorders; 5.Central Sleep Apnea 6.Psychiatric, and neurologic disorders preventing them from being compliant to treatment; 7.Patients with craniofacial abnormalities which can hamper usage of CPAP mask. 8.Patients with prior use or using the CPAP

Design outcomes

Primary

MeasureTime frame
To measure and compare the frequency domain parameters of Heart Rate Variability (LF/HF ratio, LF, HF) with reference to FP-CPAP(Fixed Pressure- Continuous Positive Airway Pressure) and APAP(Auto Positive Airway Pressure) in moderate to severe OSA(Obstructive Sleep Apnea) patients.Timepoint: At baseline, after 4weeks of initial PAP therapy, after 1 week of washout period and after 4weeks other PAP therapy—

Secondary

MeasureTime frame
To measure and compare time domain parameters (RMSSD,PNN50) of HRV (Heart Rate Variability) with reference to FP- CPAP and APAP in moderate to severe OSA patients. To measure and compare the autonomic function tests (Ewingâ??s battery of tests) with reference to FP-CPAP and APAP in moderate to severe OSA patients. Timepoint: At baseline, after 4weeks of initial PAP therapy , after 1 week of washout period and after 4weeks other PAP therapy—

Countries

India

Contacts

Public ContactDr Abhishek Goyal

AIIMS,Bhopal

abhishek.pulmed@aiimsbhopal.edu.in9630098093

Outcome results

None listed

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