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CTRI Number  CTRI/2023/10/058486 [Registered on: 10/10/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of breathing techniques and oral exercises in patients with breathing difficulties during sleep. 
Scientific Title of Study   Effect of Comprehensive Rehabilitation on Apnea Hypopnea Index in patients with Obstructive Sleep Apnea: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrudula Pawar 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  8401236509  
Fax    
Email  pawarmrudula05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prem V 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Prem V 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore


KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road,Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrudula Pawar  Manipal Hospitals Bangalore  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore
Bangalore
KARNATAKA 
8401236509

pawarmrudula05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive Rehabilitation  Functional Nasal Breathing Rehabilitation techniques Myofunctional Therapy Diaphragmatic Breathing Exercise Frequency - 3 times/day for 5 days a week Duration - For 12 weeks 
Comparator Agent  Myofunctional Therapy  Soft Palate Exercises Tongue Exercises Facial Exercises Stomatognathic functions Frequency - 3 times/day for 5 days a week Duration - For 12 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with mild and moderate OSA (with AHI ≥5 to ≤ 30)
2. BMI less than 40 kg/m2
 
 
ExclusionCriteria 
Details  1. Patients with obstructive nasal disease such as allergic rhinitis.
2. Individuals with craniofacial malformations.
3. Patients diagnosed with comorbid sleep disorders such as insomnia, restless leg syndrome.
4. Pregnant women
5. Patients with history of pharyngeal surgery.
6. Patients with history of congestive heart failure, cardiomyopathy, chronic obstructive pulmonary disease, liver cirrhosis.
7. Patients with history of neuromuscular disorders such as myasthenia gravis, motor neuron disease, demyelinating diseases.
8. Patients with history of stroke.
9. Patients with psychiatric illness such as schizophrenia, anxiety disorder, obsessive compulsive disorder, bipolar disorder, attention deficit disorder and hyperactivity disorder.
10. Consumption of alcoholic beverages regularly.
11. Periodontal disease (gingivitis)
12. Temporomandibular Joint dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Apnea Hypopnea Index
2. Epworth Sleepiness Scale 
1. At baseline (0 weeks), End of the treatment (12 weeks)
2. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Oxygen Desaturation Index
2. Snoring Index
3. Pittsburg Sleep Quality Index
4. Manual Assessment of Respiratory Motion
5. Breath Hold Test
6. Self Evaluation of Breathing Questionnaire 
1. At baseline (0 weeks), End of the treatment (12 weeks)
2. At baseline (0 weeks), End of the treatment (12 weeks)
3. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks)
4. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks)
5. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks)
6. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks) 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="118" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) 30/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

“Obstructive sleep apnea (OSA) is a breathing disorder which is sleep related, marked by episodes of decreased and complete stoppage of ventilation (hypopnea and apnea)”. It is characterized by recurrent obstruction of upper airway in sleep leading to oxyhaemoglobin desaturation and arousals from deep sleep. According to recent study reports, it was found that approximately 936 million adults of age 30 to 69 years suffer from mild to moderate OSA worldwide. In India, the prevalence of OSA was 52 million as of 2021. OSA risk increases with the age. Also, males are more commonly affected.

OSA patients present with arousals from sleep at night, which are characterized by collapse of oropharyngeal airway. It results in excessive daytime sleepiness. Moreover, loud and bothersome snoring, choking and gasping during sleep are reported by the bed partners of these individual. This is accompanied by a change in breathing pattern. There is predominant thoracic breathing with a greater paradoxical motion of the abdomen. Moreover, patients with OSA tend to do oral and oro-nasal breathing in sleep.

The episodes of hypopnea and apnea during sleep are measured by polysomnography or home sleep testing with Apnea Hypopnea Index (AHI) being a vital measure of the test for OSA patients. Pharmacological management of OSA is not approved. However,S.G. Schütz et al. concluded in the systematic review that, pharmacological treatment can be used as an adjunct therapy as it has only mild to moderate effect on OSA severity. Besides, these medications have potential negative effects. Hence, the non-pharmacological management involving continuous positive airway pressure (CPAP) is considered as the first line of treatment. Evidences have showed the effectiveness of CPAP in decreasing the severity of OSA and improving sleep quality. However, there are side effects of CPAP which results in decreased adherence of patients to the treatment.

Myofunctional therapy serves as an adjuvant treatment for OSA patients. It involves isotonic and isometric oropharyngeal exercises, targeting the tongue and pharyngeal musculature. A recent systematic review by Rueda JR et al has established the positive effects of myofunctional therapy in OSA patients. In another study, R. Courtney et al. showed the effectiveness of functional nasal breathing rehabilitation technique on patients with nasal obstruction and self reported mouth breathing. It stated that these patients reported decreased mouth breathing, reduced snoring and improved sleep. Therefore further studies are needed on this technique in patients with impaired sleep.

Comprehensive rehabilitation for OSA focuses on modification of oral and oronasal breathing, improving oropharyngeal muscles and correcting paradoxical breathing pattern. It rehabilitates the patient through functional nasal breathing techniques, isotonic and isometric oropharyngeal exercises and diaphragmatic breathing technique.

To date, literatures have reported on usefulness of CPAP and myofunctional therapy as treatment approaches for OSA patients. Thus, a randomized controlled trial can be done to see the effectiveness of comprehensive rehabilitation for OSA. The primary objectives of the study are to determine the effect of comprehensive rehabilitation on AHI and excessive day time sleepiness. The secondary objectives are to determine its effect on oxygen desaturation, snoring, sleep quality and on the components of breathing dysfunction.

 
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