It is a study comparing biomarker IL 6 , AHI score in sleep apnea patients getting mandibular advancement treatment , continuous positive airway pressure therapy.

Phase 3

• Conditions: Health Condition 1: K089- Disorder of teeth and supporting structures, unspecifiedHealth Condition 2: J988- Other specified respiratory disorders

• Registration Number: CTRI/2022/07/044139
• Lead Sponsor: Dr shilpa verma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 August 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age more than 18 years

2.Patients diagnosed with obstructive sleep apnoea syndrome based on Polysomnography [PSG] with AHI >= 5 and those who are not willing/non-compliant to Continuous Positive Airway Pressure [CPAP] therapy, referred for Oral Appliance Therapy by the Sleep physician will be included.

3.Signed written informed consent

4.Dentate patients who have sufficient number of teeth for adequate retention of MAD.

5.Healthy periodontal status

Exclusion Criteria

1.Acute or chronic inflammatory disorders

2.BMI >32kg/m2

3.Temporomandibular disorder[TMD]

4.Maximum protrusive distance less than 6 mm

5.Mental /Psychological illness

6.History of previous Neuromuscular disease /severe obstructive nasal disease

7.Craniofacial malformation

8.Patients under medication that increases weight gain or alter the respiration during sleep.

9.Other diagnosed Sleep Disordered Breathing [SDB]

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the changes in interlukin 6 levels and AHI score in Mandibular advancement device therapy and continuous positive airway pressure therapy in mild to moderate obstructive sleep apnea.Timepoint: Baseline and at 12 weeks of the therapy.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of MAD and CPAP therapy on change in IL-6 level and AHI score in cases with mild to moderate obstructive sleep apnea.Timepoint: At baseline and at 12 weeks of the therapy.