| CTRI Number |
CTRI/2024/02/062554 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How feeling sleepy during day is related to strength of breathing muscle and hand grip muscle in obstructive sleep apnea patients |
|
Scientific Title of Study
|
Correlation of Daytime sleepiness with Respiratory muscle strength and Hand grip strength in obstructive sleep apnea patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal Mistry |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9892971248 |
| Fax |
|
| Email |
hetalmistry1975@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hetal Mistry |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9892971248 |
| Fax |
|
| Email |
hetalmistry1975@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ujjwal Prakash Bhangare |
| Designation |
Post Graduate Student |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
OPD-24, Physiotherapy Department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8286896402 |
| Fax |
|
| Email |
ujjwalpbhangare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Hetal Mistry |
B.Y.L Ch Nair Hospital, |
Pulmonary Medicine OPD, 2nd floor, OPD Building, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA |
9892971248
hetalmistry1975@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G473||Sleep apnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Obstructive Sleep Apnea
AHI Score more than 5 events per hours from pulmonary department. |
|
| ExclusionCriteria |
| Details |
1 Dyspnea at rest grade 4 according to modified medical research council grading
2 Patients on Continous Positive Airway
Pressure
3 Those with major respiratory musculoskeletal or neurological diseases.
4 Hand deformity, fracture and any systemic illness
5 Patient unable to understand and follow the verbal commands
6 Major audio-visual impairment
7 Not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Epworth sleepiness scale
2 maximum inspiratory pressure and maximum expiratory pressure
3 hand grip strength |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
16/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
The aim of the study was
to assess the correlation between daytime sleepiness, respiratory muscle
strength, and hand grip strength in obstructive sleep apnea patients. To
achieve this, the study measured daytime sleepiness using the Epworth
Sleepiness Scale (ESS), Respiratory Muscle Strength (RMS) through Maximum
Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) by using a
respiratory pressure meter and hand grip strength by using a handheld
dynamometer.
It was cross-
sectional, observational and correlational study of 50 OSA patients. They were
enrolled after fulfilling the inclusion criteria and were willing to
participate in study after obtaining the written consent, the participant was
administered epworth sleepiness scale, made to assess respiratory and hand grip
muscle strength in pulmonary medicine outpatient department at tertiary health
care hospital. Data was analysed.
The results
demonstrated a significant strong negative correlation between daytime
sleepiness (measured by ESS) and respiratory muscle strength, with a
correlation coefficient of -0.604 for MIP and -0.629 for MEP, both with a
p-value of less than 0.001. This suggests that as daytime sleepiness increases,
respiratory muscle strength decreases in OSA patients. Additionally, there was
a significant weak negative correlation between ESS and hand grip strength
(r=-0.361, p=0.01), indicating that daytime sleepiness increases then hand grip
strength reduces.
This study findings
suggests that higher levels of daytime sleepiness in OSA patients are
associated with reduced respiratory and hand grip strength, potentially due to
mechanisms like intermittent hypoxia, oxidative stress, and sleep
fragmentation. These physiological disruptions may contribute to muscle
weakness, further impairing respiratory function and overall physical function
in OSA patients.
The study highlights
the importance of managing daytime sleepiness and improving muscle function
through exercise such as respiratory muscle training and hand grip training to
enhance patient outcomes. Hence, this study provides important insights into
the correlation between daytime sleepiness, respiratory and hand grip muscle
strength in OSA patients.
|