| 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
|
|
|
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
|
|
|
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)â€. 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. |