| CTRI Number |
CTRI/2024/08/072008 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Accuracy of Sleep Apnea Questionnaires in Adults: Hospital Study |
|
Scientific Title of Study
|
Diagnosis accuracy of screening questionnaires for obstructive sleep apnea in adults -a hospital based cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nakwa fathima sadaf |
| Designation |
Student |
| Affiliation |
Rajiv gandhi university of health sciences |
| Address |
Department of Pharmacology, Karavali College of Pharmacy,
Vamanjoor, Mangalore, Karnataka-575028
Dakshina Kannada
KARNATAKA
575028
India
Department of Pharmacology, Karavali College of Pharmacy,
Vamanjoor, Mangalore, Karnataka-575028
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
7337877844 |
| Fax |
|
| Email |
zaraasmaaras0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thanveer ahammed chonari |
| Designation |
Assistant Professor |
| Affiliation |
Karavali college of pharmacy |
| Address |
Department of Pharmacology, Karavali College of Pharmacy,
Vamanjoor, Mangalore, Karnataka-575028
Dakshina Kannada
KARNATAKA
575028
India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8921269228 |
| Fax |
|
| Email |
thanveerahammed24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thanveer ahammed chonari |
| Designation |
Assistant Professor |
| Affiliation |
Karavali college of pharmacy |
| Address |
Department of Pharmacology, Karavali College of Pharmacy,
Vamanjoor, Mangalore, Karnataka-575028
Dakshina Kannada
KARNATAKA
575028
India
KARNATAKA
575028
India |
| Phone |
8921269228 |
| Fax |
|
| Email |
thanveerahammed24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Mangalore, Karnataka |
|
|
Primary Sponsor
|
| Name |
Nakwa fathima sadaf |
| Address |
Department of Pharmacology, Karavali College of Pharmacy,
Vamanjoor, Mangalore, Karnataka-575028
Dakshina Kannada
KARNATAKA
575028
India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nakwa fathima sadaf |
father muller medical college |
father muller road, father muller hospital, department of pulmonology, 1st floor,kankanady-575002
Dakshina Kannada
KARNATAKA |
7337877844
zaraasmaaras0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
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 |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with obstructive sleep apnea.
Patient who presents with snoring
|
|
| ExclusionCriteria |
| Details |
Patients who are diagnosed with psychiatric illness.
Pregnant and lactating women.
Patients who are unresponsive, unconscious, and comatose.
Patients diagnosed with central sleep apnea
Patient who doesn’t give h/o of snoring
Patients who refuse to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the study result will explore the diagnostic accuracy of screening questionnaires, such as the Epworth Sleepiness Scale and STOP-BANG questionnaire, in assessing obstructive sleep apnea (OSA) among adults. These tools are widely used in clinical settings to identify individuals at risk for OSA based on symptoms and other criteria. |
0 15 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In this study, we aim to determine the demographic characteristics of patients diagnosed with obstructive sleep apnea through sleep studies, assess the positive predictive value of the Epworth Sleepiness Scale (ESS) and STOP-BANG questionnaires, and classify cases of obstructive sleep apnea into mild, moderate, and severe categories using established criteria such as the Apnea-Hypopnea Index. |
0 15 30days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction during sleep, leading to arousals and oxygen desaturation. Common symptoms include snoring during sleep and excessive daytime sleepiness or fatigue. Polysomnography (PSG) is the gold standard for diagnosis but is costly and time-consuming. Screening tools like the Epworth Sleepiness Scale (ESS) and STOP-Bang questionnaire (SBQ) offer easier, more accessible ways to assess OSA risk. PSG measures various parameters including the Apnea-Hypopnea Index (AHI) to classify OSA severity (normal, mild, moderate, severe). OSA is associated with conditions like obesity and metabolic syndrome, highlighting the need for effective screening and management strategies. |