| CTRI Number |
CTRI/2020/01/022982 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The impact of pain on sleep quality in Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
The impact of pain on sleep quality in Chronic Obstructive Pulmonary Disease - a cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjai N |
| Designation |
Post Graduate student |
| Affiliation |
KMC Manipal MAHE |
| Address |
Department of Respiratory Medicine, Kasturba Hospital,
KMC, Manipal, Karnataka, lndia.
Udupi
KARNATAKA
576104
India |
| Phone |
9353671576 |
| Fax |
|
| Email |
drsanjai8.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswini Kumar Mohapatra |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Hospital and Medical College(KMC), Manipal Academy of Higher Education |
| Address |
Department of Respiratory Medicine, Kasturba Hospital,
KMC, Manipal, Karnataka, lndia.
Udupi
KARNATAKA
576104
India |
| Phone |
9845297200 |
| Fax |
|
| Email |
aswinidr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjai N |
| Designation |
Post Graduate student |
| Affiliation |
KMC Manipal MAHE |
| Address |
Department of Respiratory Medicine, Kasturba Hospital,
KMC, Manipal, Karnataka, lndia.
Udupi
KARNATAKA
576104
India |
| Phone |
9353671576 |
| Fax |
|
| Email |
drsanjai8.7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sanjai N |
Kasturba Medical College and Hospital |
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9353671576
drsanjai8.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed to
have COPD based on 2019 GOLD guidelines. |
|
| ExclusionCriteria |
| Details |
1. COPD exacerbation within one month
2. Other chronic respiratory illness like bronchial asthma, bronchiectasis and interstitial
lung disease
3. Anyone with cardiac illnesses, those on ventilators and on psychiatry medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate sleep quality in COPD using the Pittsburgh Sleep Quality Index (PSQI)
and severity of pain using Brief Pain Inventory (BPI). |
Time of first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess functional exercise capacity using 6 Minute Walk Test (6MWT) and its association with sleep quality. To estimate the prevalence of comorbidities and their contribution to poor quality of sleep |
Time of first visit |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2020 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep. The factors affecting sleep quality not known fully. Though dyspnea, cough and expectoration can lead to disturbed sleep, pain is also a significant symptom affecting sleep quality in COPD. Increased pain has been associated with increased dyspnea, decreased exercise capacity, more reduced quality of sleep, and has negative impact of COPD. |