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Improvement of snoring by wearable dental device

Evaluation of effect of Mandibular Advancement Device on Inflammatory marker (TNF-alpha) in patients with Obstructive Sleep Apnoea: A controlled before and after study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025646
Enrollment
20
Registered
2020-06-05
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: G473- Sleep apnea

Interventions

Intervention1: Mandibular advancement device: Patients with obstructive sleep apnoea will be given intervention with treatment by mandibular advancement device and observed. Control Intervention1: NIL

Sponsors

Office of the Research Cell
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Serum TNF-alpha levelsTimepoint: Baseline 3 months 6 months

Secondary

MeasureTime frame
Epworth sleepiness scale Berlin questionnaire Stop-Bang questionnaireTimepoint: baseline 3 months 6 months

Countries

India

Contacts

Public ContactNeeti Solanki

King Georges Medical University

dr.pooran_chand@yahoo.com9415173419

Outcome results

None listed

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