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comparison of two different modalities for treatment of Obstructive Sleep Apnoea

Comparison of efficacy and effectiveness of titratable mandibular advancement device (MDSA) and Continuous Positive Airway Pressure (CPAP) therapy in treatment of OSA : A clinical cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013345
Enrollment
30
Registered
2018-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Obstructive Sleep Apnea

Interventions

Intervention1: Mandibular advancement device: Half of the patients will be randomly selected for CPAP and MDSA to begin treatment and objective evaluation will be done before treatment determining AHI

Sponsors

office of the DIRECTOR GENERAL ARMED FORCES MEDICAL SERVICES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed adult cases of OSA Mild OSA â?? AHI 10-20 Moderate OSA- AHI 20-30 Severe OSA AHI greater than 30 2. Cases showing improvement in airway with mandibular advancement. 3. Those having minimum component of dentition to support MDSA. 4. Those who have mandibular protrusive movement of more than 5 mm. 5. Those who give consent to take part.

Exclusion criteria

Exclusion criteria: 1. Central OSA 2. Obesity (BMI less than 30) 3. Systemic complication

Design outcomes

Primary

MeasureTime frame
Changes in AHI, Oxygen saturation and Epworth Sleepiness scale scoresTimepoint: 2 months—

Secondary

MeasureTime frame
airway changes in acoustic pharyngometryTimepoint: 2 months—

Countries

India

Contacts

Public ContactDr Shiv Shankar Agarwal

Armed Forces Medical College Pune

docshivagarwal@rediffmail.com7086104044

Outcome results

None listed

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