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CTRI Number  CTRI/2018/06/014442 [Registered on: 07/06/2018] Trial Registered Retrospectively
Last Modified On: 11/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Sleep related breathing disorders in copd and osa-overlap syndrome patients 
Scientific Title of Study   To study the profile of various sleep related breathing disorders in patients with overlap syndrome and its therapeutic implications  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  pranav 
Designation  DM Resident 
Affiliation  VMMC AND SJH 
Address  Ward 32, 3rd floor, Casualty Block, Department of Pulmonary, critical care and Sleep medicine, VMMC AND Safdarjung Hospital, New Delhi 110029

South
DELHI
110016
India 
Phone  9958356000  
Fax    
Email  pranavish2512@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  J C Suri 
Designation  Professor and Head 
Affiliation  VMMC AND Safdarjung hospital 
Address  Ward 32, 3rd floor, Casualty Blcok, Department of Pulmonary, critical care and Sleep medicine, VMMC and Safdarjung Hospital, New Delhi 110029

South
DELHI
110016
India 
Phone  9810097259  
Fax    
Email  docjcsuri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  pranav 
Designation  DM RESIDENT 
Affiliation  VMMC AND SJH 
Address  Ward 32, 3rd floor, Casualty Blcok, Department of Pulmonary, critical care and Sleep medicine, VMMC AND SAFDARJUNG Hospital, New Delhi 110029

South
DELHI
110016
India 
Phone  9958356000  
Fax    
Email  pranavish2512@gmail.com  
 
Source of Monetary or Material Support  
NONE 
 
Primary Sponsor  
Name  Dept of pulmonary critical care and sleep medicine Vmmc and Safdarjung hospital 
Address  VMMC AND SJH, NEW DELHI-110029 
Type of Sponsor  Government 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 
PRANAV  Safdarjung Hospital  Ward 32, 3rd floor, Casualty Block, Dept of pulmonary critical care and sleep medicine, Vmmc and Safdarjung hospital , New Delhi-110029
South
DELHI 
9958356000

pranavish2512@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  COPD patients with OSA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NONE  NONE 
Intervention  Pap titration for overlap patients  Patients with copd and osa documented were titrated with split night polysomnography using various modes of positive airway pressure therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with age>18 years of age

2. Patients with confirmed OSA on Polysomnography (PSG) as defined by Apnea hypopnea index (AHI) >5/hour and obstructive pattern on spirometry as evident by post
bronchodilator FEV1/FVC ratio < 0.7 
 
ExclusionCriteria 
Details  patient unfit to undergo spirometry 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the profile of sleep related breathing disorders in Overlap syndrome
• To determine optimal PAP therapy in Overlap syndrome 
None defined as not a follow-up study 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2015 
Date of Study Completion (India) 30/04/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOT PUBLISHED YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
SUMMARY

Background-Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA)
represent two of the most prevalent chronic respiratory disorders in clinical practice, the
coexistence of which is referred to as the overlap syndrome. López-Acevedo et al. reported that
overlap syndrome occurs in 10–20% of patients with OSA. A recent comprehensive review
indicates that the two disorders coexist in approximately 1% of adults. Thus overlap syndrome is
not uncommon. There is paucity of literature on the profile of Sleep related breathing disorders
(SRBD) in overlap syndrome. There are no consensus guidelines to positive airway pressure
(PAP) titration in overlap syndrome.

Methods- The study was conducted in the department of Pulmonary, Critical care and Sleep
medicine, Safdarjung hospital from December 2015 to April 2017 in patients presenting with
COPD and history suggestive of sleep disordered breathing. It was a prospective observational
study. A minimum of 30 patients were to be included in the study as a sample size of
convenience. In view of absence of any large prospective trial on this field of research and also
considering average annual rate of patients with overlap syndrome as 30, this study was a pilot
study with minimum sample size of 30.

Results- All patients presenting to Respiratory department with history suggestive of COPD
underwent a post bronchodilator spirometry to confirm the diagnosis and were be classified
according to GOLD staging as well as Groups A to D according to severity, symptoms and
exacerbations. History regarding excessive daytime sleepiness, snoring, early morning headache,
lethargy and fatigue was taken and Epworth sleepiness score was calculated. Those found to
have an AHI more than 5/hour in the diagnostic part were labelled as overlap syndrome. Thirty
seven such patients were included in the study. The underlying sociodemographic profile of the
patients was suggestive of a predominant male and middle aged population. Most of the patients
(81%) had moderate to severe obstruction in spirometry and only around 5% had mild
obstruction on classifying into COPD groups. On evaluation of the profile of sleep disordered
breathing found in these patients, it was seen that only around half of the patients had pure
obstructive sleep apnea with no hypoventilation. Around 35.1% of the patients had associated
hypoventilation with OSA. Around 5.4% patients had cheynes stokes breathing (hypocapnic
central sleep apnea) and rest had OSA with central sleep apnea along with hypoventilation. Pure
OSA group was easily titrated by OSA titration guidelines of AASM and were easily corrected
by CPAP therapy. OSA with hypoventilation group were mostly severe COPD with hypercapnia,
they required Bilevel PAP titration to correct rise in co2 to awake levels. Transcutaneous CO2
monitoring was done to document hypoventilation Patients with hypoventilation and central
sleep apnea needed a back up rate for correction and were given bilevel PAP with S/T mode for
correction. Patients with cheyne stokes breathing were elderly hypertensive patients with
congestive heart failure who were corrected by PAP and optimisationof medical therapy for heart
failure. Our study also did not demonstrate any correlation with degree of obstruction and AHI.
So, we divided our patients into 4 groups on the basis of severity of the two underlying diseasesmild-
moderate COPD with mild-moderate OSAHS, mild-moderate COPD with severe OSAHS,
severe COPD with mild-moderate OSAHS, severe COPD with severe OSAHS and analysed
their symptoms, examination, ABG and polysomnography charecteristics. Most of the
charecteristics like age ,sex, smoking history, Epworth sleepiness score were well distributed
among these groups with ANNOVA analysis showing p value >0.05. Pulmonary hypertension
and evidence of cor-pulmonale was highly evident in the severe COPD groups and systemic
hypertension was present in 5/7 patients in severe COPD and severe OSA group. However, the
comorbidties distribution was not statistically significant.
These findings also give us clinical hints as to when to suspect which profile of SDB when
considering a patient for PSG titration so that appropriate titration can be done and various
modes of PAP therapy can be appropriately advised. There are currently no defined guidelines
for titration of such overlap patients. In view of overlap disease not being uncommon, and the
titration issues discussed above, further large scale studies are required to evaluate titration of
such patients and formulating guidelines for the same.

CONCLUSIONS AND RECOMMENDATIONS
1. Overlap syndrome is defined as overlap of OSA with COPD, however it can present with
varied sleep-disordered breathing profiles. Only around half of the patients have pure
OSA which can be titrated according to AASM guidelines.
2. These profiles include OSA, hypoventilation, cheyne-stokes breathing and central sleep
apnea
3. Evaluation of the above mentioned profiles is necessary to treat such patients
appropriately as various PAP types and devices may be required for correction of the
same
 
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