| CTRI Number |
CTRI/2026/01/100090 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
comparision of two exercises programs for the tongue and throat in people with obstructive sleep apnea for 12 weeks |
|
Scientific Title of Study
|
Effect of Oropharyngeal Exercises compared to Tongue proprioceptive Neuromuscular Facilitation in 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 |
ATMAKURI DEEPTHI |
| Designation |
POST GRADUATE |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
MALLA REDDY UNIVERSITY, MAISAMMAGUDA, DULLAPALLY, HYDERABAD, TELANGANA 500100
Medchal
TELANGANA
500100
India |
| Phone |
8179932281 |
| Fax |
|
| Email |
atmakurideepthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SWATI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
MALLA REDDY UNIVERSITY , MAISAMMAGUDA, DULLAPALLY, HYDERABAD , TELANGANA, 500100
Medchal
TELANGANA
500100
India |
| Phone |
8247764969 |
| Fax |
|
| Email |
ganaparthi.swathi@mallareddyuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SWATI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
MALLA REDDY UNIVERSITY , MAISAMMAGUDA, DULLAPALLY, HYDERABAD , TELANGANA, 500100
Medchal
TELANGANA
500100
India |
| Phone |
8247764969 |
| Fax |
|
| Email |
ganaparthi.swathi@mallareddyuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| MALLA REDDY UNIVERSITY OF HEALTH SCIENCES |
|
|
Primary Sponsor
|
| Name |
ATMAKURI DEEPTHI |
| Address |
MALLA REDDY UNIVERSITY, MAISAMMAGUDA, DULAPALLY, HYDERABAD, TELANGANA, 500100 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ATMAKURI DEEPTHI |
MALLA REDDY HEALTH CITY |
DEPARTMENT OF PHYSIOTHERAPY, SLEEP MEDICINE UNIT-PHYSIOTHERAPY SECTION
Medchal
TELANGANA |
8179932281
atmakurideepthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteForBiomedicalAndHealthResearch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OROPHARYNGEAL EXERCISES |
Participants will perform targeted exercises, including soft palate and tongue base strengthening exercises, for 8 weeks . exercises will include tongue stretches, soft palate lifts , and lip sealing techniques. |
| Comparator Agent |
TONGUE PROPRIOCEPTIVE NEUROMUSCULAR EXERCISES |
participants will undergo tongue proprioceptive neuromuscular facilitation techniques focusing on resistance based movements to improve tongue muscles coordination and strength. exercises will include tongue protrusion, retraction, lateralization and resistance training. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
. adults aged 18 to 65 years diagnosed with mild to moderate OSA . individuals with Apnea Hypopnea index between 5 to 30 events per hour . patients willing to participate and comply with the interventions |
|
| ExclusionCriteria |
| Details |
1) severe OSA Apnea Hypopnea index more than 30. 2) history of upper airway or neurological disorders affecting or oropharyngeal muscles. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Apnea-Hypopnea Index
Epworth Sleepiness Scale |
12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE |
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The Effect of Oropharyngeal Exercises and Tongue Proprioceptive Neuromuscular Facilitation in improving sleep quality, reducing Apnea Hypopnea Index and enchancing airway muscle function in patients with Obstructive Sleep Apnea. Null hypothesis is there is no significant differance between Oropharyngeal Exercises and Tongue PNF in improving OSA symptoms with alternative hypothesis that there is significant differance between Oropharyngeal Exercises or Tongue PNf in improving OSA symptoms |