| CTRI Number |
CTRI/2025/10/095692 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of strengthening genioglossal and palatoglossal muscles in case of obstructive sleep apnea |
|
Scientific Title of Study
|
Effect of strengthening genioglossal and palatoglossal muscles using a spring based device on 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 |
Srishty goyal |
| Designation |
MPT (Cardiopulmonary) |
| Affiliation |
Sharda university |
| Address |
Physiotherapy department, Sharda university
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7007061734 |
| Fax |
|
| Email |
srigoyal1089@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mayank Shukla (PT) |
| Designation |
Professor |
| Affiliation |
Sharda university |
| Address |
Department of Physiotherapy, Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9711113097 |
| Fax |
|
| Email |
mayank.shukla1@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Srishty goyal |
| Designation |
MPT (Cardiopulmonary) |
| Affiliation |
Sharda university |
| Address |
Department of physiotherapy, Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7007061734 |
| Fax |
|
| Email |
srigoyal1089@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Srishty Goyal |
| Address |
Sharda University, plot no. 32, 34, Knowledge park III, Greater Noida, Uttar Pradesh, 201310 |
| Type of Sponsor |
Other [Independent] |
|
|
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 Srishty goyal PT |
Sharda University |
Department of Physiotherapy, Sharda University, plot no. 32 34, Knowledge Park III, Greater Noida, Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH |
7007061734
srigoyal1089@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Science and Research and Sharda Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Muscle strengthening (Oral spring-based device)
|
Group A- Deep breathing with pursed lip breathing, thoracic expansion with neck extension, jaw and tongue ROM and Muscle strengthening (Oral spring-based device)
Duration of study is 1 year
|
| Comparator Agent |
Group B- Placebo Therapy |
Group B- Deep breathing with pursed lip breathing, thoracic expansion with neck extension, jaw and tongue ROM
Duration of study is 1 year |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Witnessed apnea while sleeping- 14 and above event per hour according to AHI that is moderate to severe.
2. Snoring- Positive or Negative.
3. Fatigue- According to Fatigue Severity Scale if a person scores more than 36.
4. Unrefreshing sleep- A person score 9 and above according to ESS.
5. Overweight.
6. Well conscious and oriented. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy.
2.Ventilated patient.
3.Unconscious and non-oriented.
4.Oral Infection.
5.Use of CPAP.
6.Upper airway surgery.
7.Neuromuscular disorder.
8.Temporomandibular joint disorder or severe jaw pain.
9.Severe Dental issue.
10.Buccal mucosa carcinoma. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Apnea Hypopnea Index (AHI)
2.Epworth Sleepiness Scale (ESS) |
3 week and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMT of Tongue |
3 week & 6 week |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 1 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - NO
|
|
Brief Summary
|
A randomized controlled trial would be conducted at department of physiotherapy, Sharda Hospital. Age group will be sorted between 30-60 years both male and female. OSA patients (N=) will be selected and randomized via chit method into two groups. Interventional Session will be held on 3 days per week for 6 weeks. The patients will be selected according to the inclusion and exclusion criteria. The patients will be educated about the treatment and the procedure they are going to receive and its benefits. An ethical approval and informed consent will be taken. The two groups will be categorized in which Group A will receive tongue muscle strengthening exercise by using a spring-based device (IPR No-504718 has been granted for the device) in which the strengthening of Genioglossal and Palatoglossal muscles of tongue will be held in different directions (Laterally, Upward and Downward) which can lead to the improvement of sleep apnea severity and also improves overall sleep quality. At first week the treatment will be started with a minimum resistance and it will increase gradually after a week. Group B will receive placebo treatment in which they receive an inactive treatment. The outcome measures will be recorded according to the Apnea hypopnea scale (AHS) and Epworth sleepiness scale (ESS) as pre and post intervention. |