| CTRI Number |
CTRI/2024/02/062555 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| 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 the day is related to ability to do things and overall tiredness in people with a condition called obstructive sleep apnea |
|
Scientific Title of Study
|
Correlation of daytime sleepiness with functional capacity and fatigue 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 |
Razia begum jamil ahmed Shaikh |
| 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-400008 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-400008 Mumbai MAHARASHTRA 400008 India |
| Phone |
8591501339 |
| Fax |
|
| Email |
shaikhraziya10@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. Nair Charitable 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 BYL 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 medicine 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 Comorbity.
4 Systolic blood pressure more than 180 mmhg
5 Resting DBP more than 100 mmhg
6 Resting HR more than 120 bpm
7 Assistive aids for walking
8 Major audio-visual impairment
9 Patients unable to understand and follow the verbal commands
10 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 (ESS).
2.Six-minute walk test(6MWT).
3.Fatigue severity scale(FSS). |
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
Modification(s)
|
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)
|
Obstructive Sleep Apnea (OSA) has
been recognised as a major cause of morbidity and mortality in developing
countries like India. It is characterised by repeated episode of partial
(hypopnea) or complete (apnea) upper airway obstruction
during sleep that lead to snoring, frequent
episode of sleep
interruption, hypoxemia, hypercapnia, swing in intrathoracic pressure and increased sympathetic activity. Excessive Daytime
Sleepiness (EDS) is prominent symptom of Obstructive Sleep Apnea (OSA) and
which is measured by Epworth sleepiness scale (ESS). Functional capacity is an
important dimension in human functioning. The six- minute walk test is easier
to administer, better tolerable and more representative of activities of daily
living than any other walking test. Fatigue is primarily a subjective
experience that includes physiological performance decrements and psychological
impairments such as decreased morale, judgement and mood.
Perception of fatigue
measured by the Fatigue Severity
Scale (FSS).
The Aim of our study was to find
the correlation of epworth sleepiness scale with functional capacity and
fatigue in obstructive sleep apnea patients.
It was a cross-sectional,
observational, correlation study of 50 OSA patients. They were enrolled after
fullfiled the inclusion criteria and were willing to participate in study.
After obtaining the written consent, the participants were administrated epworth
sleepiness scale, fatigue severity scale and made to perform six-minute walk
test in pulmonary medicine Out Patient Department at
tertiary health care hospital. The time required was 30-35 minutes.
Data was collected and analysed for normality by
shapiro-wilk test. Since, the epworth sleepiness scale and fatigue
severity scale are likert scale,
Spearman’s rho correlation was done to find the correlation of epworth sleepiness scale with functional capacity and fatigue
severity scale in obstructive sleep apnea patients.
It was observed that there
is significant moderate negative correlation between Epworth Sleepiness Scale
(ESS) and percentage predicted value of 6MWT (Functional Capacity) with r value
of -0.597 and p value
of 0.001. Also,
a significant moderate
positive correlation between Epworth Sleepiness Scale (ESS) and
Fatigue Severity Scale (FSS) with r value of 0.492 and
p value of 0.001 was observed. Thus, the alternate hypothesis was proved to be
corrected. |