Improvement of snoring by wearable dental device

Phase 4

• Conditions: Health Condition 1: G473- Sleep apnea

• Registration Number: CTRI/2020/06/025646
• Lead Sponsor: Office of the Research Cell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects in the age group of 25-65 years.

2. Ability to understand the procedure and provide informed consent before being included in the study.

3. Patients with mild to moderate Obstructive Sleep Apnoea.

4. Patients with no previous OSA treatment history.

5. >8 stable natural teeth per jaw with no periodontal condition like periodontitis etc.

Exclusion Criteria

1. Current smoking habit with moderate to heavy smoking (more than 10 cigarettes per day).

2. History of infectious diseases, rheumatic diseases, immunological diseases, tumours, peripheral vascular diseases, coagulation disorders, severe psychogenic disorders, or acute or chronic kidney failure.

3. History of injury or surgery in past three months.

4. Administration of drugs (anti-inflammatory, TNF- α blockers), hormones, immune suppressors, cytotoxins, free radical scavengers.

5. OSA patients already receiving/received treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum TNF-alpha levelsTimepoint: Baseline <br/ ><br>3 months <br/ ><br>6 months

Secondary Outcome Measures

Name	Time	Method
Epworth sleepiness scale <br/ ><br>Berlin questionnaire <br/ ><br>Stop-Bang questionnaireTimepoint: baseline <br/ ><br>3 months <br/ ><br>6 months