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CTRI Number  CTRI/2023/12/060461 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between different methods of sleep study in patients with Obstructive Sleep Apnoea. 
Scientific Title of Study   Comparison between interval titration study with conventional overnight titration study in patients with Obstructive Sleep Apnoea: A Prospective, randomized 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  Thomas Antony 
Designation  Assistant Professor 
Affiliation  Kasturba Medicall College 
Address  Room No 15, Respiratory Medicine OPD Kasturba Medical College Hospital, Attavar

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8547437931  
Fax    
Email  t.antony5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Thomas Antony 
Designation  Assistant Professor 
Affiliation  Kasturba Medicall College 
Address  Room No 15, Respiratory Medicine OPD, Kasturba Medical College Hospital, Attavar

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8547437931  
Fax    
Email  t.antony5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Thomas Antony 
Designation  Assistant Professor 
Affiliation  Kasturba Medicall College 
Address  KMC, Mangalore


KARNATAKA
575001
India 
Phone  8547437931  
Fax    
Email  t.antony5@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Department of Respiratory Medicine, Room No 15, Attavar, Mangalore 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, Attavar, Mangalore, Dakshina Kannada Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Thomas Antony  Kasturba Medical College  KMC, MAngalore
Dakshina Kannada
KARNATAKA 		 8547437931

t.antony5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College,Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional CPAP titration group  CPAP will be given next day after the diagnosis of sleep apnoea 
Intervention  Interval CPAP titration group  CPAP titration will be done after a trial of 2 weeks of CPAP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients diagnosed to have obstructive sleep apnea (AHI≥15) using a level 5 polysomnography are included in the study. 
 
ExclusionCriteria 
Details  a. Age less than 18 years
b. Patients who refuse to give consent
c. Patients with known psychiatric disorders
d. Patients with hemodynamic instability
e. Patients who are not willing to use CPAP
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare the sleep efficiency among patients with conventional overnight CPAP titration and those with interval CPAP titration using polysomnography.
2. To compare the acceptability of CPAP among patients with conventional overnight CPAP titration and those with interval CPAP titration using a CPAP perception questionnaire.(9)
3. To compare the CPAP compliance at three months among those with overnight and interval CPAP titration using a proforma. 		 Interval titration group:
Baseline: sleep efficiency using titration study
Anxiety score using BAI
At 3 Months: Compliance to CPAP using questionnaire
Anxiety score using BAI
Conventional overnight titration group:
Baseline: sleep efficiency using titration study
Anxiety score using BAI
At 3 Months: Compliance to CPAP using questionnaire
Anxiety score using BAI 
 
Secondary Outcome  
Outcome  TimePoints 
 To compare the level of anxiety among patients who underwent overnight CPAP titration study and those with interval CPAP titration at baseline and three months using the BAI questionnaire  At baseline, 3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/12/2023 
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="1"
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  

A trial of CPAP before the titration study could give the patient time to adjust to the CPAP and could improve the study efficiency. Hence, we propose that a trial of CPAP before the titration could improve sleep efficiency, reduce mean CPAP pressure during the titration study, reduce CPAP-related anxiety, and improve long-term compliance with CPAP.

After obtaining the informed written consent, patients who meet the inclusion criteria are randomized into two groups (Group A & B) using a computer-generated randomization table. The study will begin after approval from the institutional ethics committee and the medical superintendent. Patients belonging to Group A will receive a CPAP titration study the following night (conventional CPAP titration study). Patients belonging to group B will receive auto CPAP for a minimum duration of two weeks, followed by a level 1 overnight CPAP titration study (interval CPAP titration study)

 
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