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

COMPARATIVE EVALUATION OF INTERLUKIN-6 LEVELS AND AHI SCORE BETWEEN MANDIBULAR ADVANCEMENT DEVICE GROUP AND CONTINUOUS POSITIVE AIRWAY PRESSURE GROUP IN OBSTRUCTIVE SLEEP APNEA PATIENTS - A PILOT STUDY

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044139

Enrollment

Registered

2022-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-08-02

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

Conditions

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

Interventions

Intervention1: evaluation of interlukin 6 levels , AHI score in patients treated with mandibular advancement device: patients will be evaluated and compared from baseline after 12 weeks for interlukin

Eligibility

Inclusion criteria

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

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]

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactDR DHEERAJ KUMAR KOLI

CENTRE FOR DENTAL EDUCATION AND RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES

dr.dheerajkoli@gmail.com09958661988

Outcome results

None listed

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