| CTRI Number |
CTRI/2025/04/084677 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study sleep apnea and clicial co morbidities in association with sleep apnea |
|
Scientific Title of Study
|
Clinical Profile of Obstructive sleep apnea and OSA with Associated Comorbidities |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBollineni Sree Prada |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe institute of Higher Education And Research |
| Address |
Respiratory Medicine Department
Jawaharlal nehru medical college
Sawangi,Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9740381395 |
| Fax |
|
| Email |
sreeprada.b9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ulhas Jadhav |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe,Wardha,Maharashtra,442001,India |
| Address |
Respiratory Medicine Depaetment
Jawaharlal nehru medical college
Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970819099 |
| Fax |
|
| Email |
dr.ulhasjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ulhas Jadhav |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe,Wardha,Maharashtra,442001,India |
| Address |
Respiratory Medicine Depaetment
Jawaharlal nehru medical college
Sawangi, Meghe, Wardha
MAHARASHTRA
442001
India |
| Phone |
9970819099 |
| Fax |
|
| Email |
dr.ulhasjadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi Meghe,Wardha,Maharashtra,442001,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
SawangiMeghe,Wardha,Maharashtra,442001,India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrBollineni Sree Prada |
Datta Meghe Institute of Higher Education and Research |
Respiratory Medicine department,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA |
9740381395
sreeprada.b9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , ,Sawangi Meghe,Wardha,Maharashtra,442001,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having symptoms of Obstructive Sleep Apnea(elaborate) |
|
| ExclusionCriteria |
| Details |
Not willing to give consent
Non compliant patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Clinical parameters in obstructive sleep apnoea and its association with other comorbidities. |
Assessment will be done at 24 hours. Overall assessment will be done at the end of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adult sleep disorder breathing is present when repetitive apnoea and hypopnea occurs during sleep. Apnoea is defined as cessation of breathing lasting at least 10seconds in duration and can be obstructive or central. Obstructive apnoea- no air flow despite continuous respiratory efforts. Central apnoea- No airflow with no respiratory efforts. Mixed Apnoea-initially appearing as central in origin and later followed by respiratory efforts.. This study being conducted is an observational, cross sectional study assessing various parameters and clinical comorbidities associated with sleep apnoea and assessment of severity index of sleep apnoea.
|