| CTRI Number |
CTRI/2024/11/076839 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to Compare Effectiveness of Prosthodontic Intervention using Soft Palate Lift Appliance along with Nabho Mudra in the Management of Obstructive Sleep Apnea |
|
Scientific Title of Study
|
A Study to Evaluate the Effectiveness of Combination of Soft Palate Lift Appliance and Nabho Mudra in the Management of Obstructive Sleep Apnea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KEVIN REJI K |
| Designation |
Post Graduate Student |
| Affiliation |
KANNUR DENTAL COLLEGE |
| Address |
Department of Prosthodontics
Room no. 5
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kereala
PIN - 670612
Kannur
KERALA
670612
India |
| Phone |
9480765731 |
| Fax |
|
| Email |
kevinrejik1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANAND K.S. |
| Designation |
Professor |
| Affiliation |
KANNUR DENTAL COLLEGE |
| Address |
Department of Prosthodontics
Room no. 5
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kereala
PIN - 670612
Kannur
KERALA
670612
India |
| Phone |
9846723844 |
| Fax |
|
| Email |
draksmds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KEVIN REJI K |
| Designation |
Post Graduate Student |
| Affiliation |
KANNUR DENTAL COLLEGE |
| Address |
Department of Prosthodontics
Room no. 5
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kereala
PIN - 670612
Kannur
KERALA
670612
India |
| Phone |
9480765731 |
| Fax |
|
| Email |
kevinrejik1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kevin Reji K
Post Graduate Student
Department of Prosthodontics
Room no. 5
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kereala
PIN - 670612
|
|
|
Primary Sponsor
|
| Name |
KEVIN REJI K |
| Address |
Department of Prosthodontics
Room no. 5
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kereala
PIN - 670612
|
| Type of Sponsor |
Other [Personal Interest] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kevin Reji K |
Kannur Dental College |
Department of Prosthodontics
Room no. 5
Anjarakandy Integrated Campus
Anjarakandy P.O.
Kannur, Kerala
PIN - 670612
Kannur
KERALA |
9480765731
kevinrejik1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE KANNUR DENTAL COLLEGE (IECKDC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NABHO MUDRA |
Nabho Mudra is practiced along with Ujjayi breathing for six months. The subject should sit straight comfortably on a chair and the Nabho mudra is performed by touching the tip of the tongue to the centre of the Palate. Ujjayi breathing is practiced by closing eyes and lips should be sealed. Deep breathes are taken through the nose and breaths will make a sound similar to the waves of an ocean. It involves Abdominal breathing, Diaphragmatic breathing and Clavicular breathing. During inhalation, initially the abdomen should expand followed by contraction and moving down of diaphragm and ends with upper ribs and collar bone pulled upwards. During exhalation, the abdomen should contract inwards, diaphragm rises and upper ribs and collar bone returns to original position. Each subject will be advised to practice this yoga technique for 15 mins, before sleep and after waking up daily. |
| Intervention |
SOFT PALATE LIFT APPLIANCE |
Soft Palate Lift Appliance is a Prosthodontic appliance which should be used continuously for 6 months for 15 minutes morning and evening that displaces soft palate superiorly and its regular usage leads to stiffening of soft palate musculature and enhance the airway passage by increasing the upper pharyngeal dimensions. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Snoring
Excessive daytime sleepiness
Witnessed breathing interruptions
Increased neck circumference
Soft palate elongation
Macroglossia
Tonsillar enlargement
Nocturia
Morning headache
|
|
| ExclusionCriteria |
| Details |
Systemic diseases and hospitalization
Hypersensitive Gag Reflex
Morphologic abnormalities such as Retrognathia , Pierre-Robin syndrome
History of Drug and Alcohol addiction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved effect in the management of obstructive sleep apnea using combination of soft palate lift appliance and Nabho Mudra |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved effect in the management of obstructive sleep apnea using soft palate lift appliance & Nabho Mudra individually. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kevinrejik1997@gmail.com].
- For how long will this data be available start date provided 11-12-2025 and end date provided 11-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Obstructive Sleep Apnea is a disorder characterized by repeated episodes of partial or complete obstruction of the upper airways. A flaccid, low-draped soft palate leads to vibration of uvula, causes snoring and as further complication, soft palate collapses and blocks the airways during sleep. Clinical manifestations of OSA are recurrent apnea (the severity of OSA is determined by Apnea-Hypopnea Index (AHI) – 5.0 – 14.9 events/h in mild OSA, 15 – 30 events/h in moderate OSA and > 30 events/h in severe OSA), hypoxia, increased negative intrathoracic pressure causing impaired CNS, CVS and metabolic function. Soft Palate Lift Appliance displaces soft palate superiorly and its regular usage leads to stiffening of soft palate musculature and enhance the airway passage by increasing the upper pharyngeal dimensions. Yoga is an earliest Indian physical, mental and spiritual practice. Various Asnas and Mudras are used as Therapeutic practices. |