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This study is to check the efficiency of newly designed upper jaw device in comparison with the conventionally used lower jaw device in the patient suffering from a moderate type of sleeping disorder

COMPARATIVE EVALUATION OF THE EFFICACY OF CUSTOMISED MAXILLARY ORAL APPLIANCE AS A TREATMENT MODALITY FOR MODERATE OBSTRUCTIVE SLEEP APNEA WITH THOSE OBSERVED IN PATIENTS WITH MANDIBULAR ADVANCEMENT APPLIANCE - A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026936
Enrollment
40
Registered
2020-07-31
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: J988- Other specified respiratory disorders Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Customized maxillary oral appliance: For Patients suffering from sleep apnea for 3 months and will be evaluated on 1st day after, one month and after 3 months of use of the appliance Co

Sponsors

Datta Meghe Institute of Medical Sciences DU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patients diagnosed with moderate OSA (apnea-hypopnea [AHI] >5â??15) 2. Patients non-compliant to CPAP and refused surgical intervention. 3. Age ranging from 30 to 50 years 4. BMI (range 17-39 kg/m2)

Exclusion criteria

Exclusion criteria: 1. A patient diagnosed with severe OSA 2. Uncooperative Subjects 3. Patients with severe periodontal diseases 4. An edentulous arch, or without a sufficient number of teeth for the adequate retention of the appliance. 5. Patients with temporomandibular joint disorders 6. Patients with pathologic evidence of airway obstruction also were excluded.

Design outcomes

Primary

MeasureTime frame
Apneaâ??Hypopnea Index (AHI)Timepoint: one month three month

Secondary

MeasureTime frame
â??Oxygen saturation in blood â??Percentage of Rapid Eye Movement (REM) â??Electroencephalogram(EEG) â??Electrocardiogram (ECG) â??Oro-nasal airflow via pressure transducer â??Epworth Sleepiness scale Timepoint: one month three month

Countries

India

Contacts

Public ContactVikram Murlidhar Belkhode

Sharad Pawar Dental College And Hospital

drsurekhadubey@gmail.com9766243887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026