CTRI

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CTRI Number

CTRI/2025/02/080191 [Registered on: 10/02/2025] Trial Registered Prospectively

Last Modified On:

10/02/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Nighttime Symptoms and Their Effects on Sleep Quality and Life in COPD Patients

Scientific Title of Study

Impact of Nocturnal Symptoms on Sleep Quality and Quality of Life Among Patients with Chronic Obstructive Pulmonary Disease

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Juno J Joel
Designation	Assistant Professor
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences,(Nitte Deemed to be University), Deralakatte, Mangaluru Dakshina Kannada, KARNATAKA 575018 India Dakshina Kannada KARNATAKA 575018 India
Phone	9480470727
Fax
Email	junojoel@nitte.edu.in

Details of Contact Person
Scientific Query

Name	Dr Juno J Joel
Designation	Assistant Professor
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences,(Nitte Deemed to be University), Deralakatte, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Phone	9480470727
Fax
Email	junojoel@nitte.edu.in

Details of Contact Person
Public Query

Name	Jnanesh Ullal
Designation	Student
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences,(Nitte Deemed to be University), Deralakatte, Mangaluru Dakshina Kannada, KARNATAKA 575018 India Dakshina Kannada KARNATAKA 575018 India
Phone	7975562924
Fax
Email	jnaneshu20@gmail.com

Source of Monetary or Material Support

K S Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka, India- 575018

Primary Sponsor

Name	Nil
Address	Nil
Type of Sponsor	Other [Nil]

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 Adarsha Shetty	Justice KS Hegde Charitable Hospital	Room No. 14, Department of Pulmonary Medicine. Dakshina Kannada KARNATAKA	8168366482 dradarshshetty@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J449\|\|Chronic obstructive pulmonary disease, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Patients of either gender visiting Out-patient as well as in-patient, aged above 18 years diagnosed with COPD and receiving treatment for the same. Patient who can read and understand either Kannada, English, or Malayalam. Patient who give their consent for the study.

ExclusionCriteria

Details

Patients with Psychiatric illness, Cancer and Pregnant women.
Patients with co-morbidities that affect their sleep quality and quality of life.
Patients who refuse to give consent for the study

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
This study is expected to provide valuable insight into the impact of nocturnal symptoms on COPD exacerbations and progression. It will also highlight the effects on sleep quality and quality of life, and potential co-relations between the two.	At Baseline only (single time point)

Secondary Outcome

Outcome	TimePoints
To analyze the effect of nocturnal symptoms on sleep quality and quality of life, and potential co-relations between the two.	Date of hospital Visit

Target Sample Size

Total Sample Size="105"
Sample Size from India="105"
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)

21/02/2025

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="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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

Introduction

Chronic Obstructive Pulmonary Disease (COPD) is a common progressive lung disease characterized by persistent respiratory symptoms and airflow limitations, often due to the destruction of alveolar walls, thickening of the bronchial walls, and mucus accumulation

Aim of the study
to analyze the impact of nocturnal symptoms on sleep quality and quality of life among patients with COPD

Objectives of the study

To assess the risk factors, frequency, and severity of nocturnal symptoms among COPD patients.
To determine the sleep quality and quality of life among the study population.
To analyze the effect of nocturnal symptoms on sleep quality and quality of life.

Methodology
It is a Prospective Cross-sectional Study that follows the Random Sampling method, conducted in the Department of Pulmonary Medicine, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru. The study will be conducted for 6 months on a sample size of 105 participants who are aged above 18 years of age and are diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and currently receiving treatment for the same and have given their consent for the study. The confidentiality of the participants will be assured. The Participants will be provided questionnaires (COPD Nocturnal Symptom Severity Questionnaire, SGRQ-C, WHO-BREF, PSQI) in their language of choice (English, Kannada, Malayalam) where their responses will help us assess and analyze the Quality of Life and Sleep quality of the study participants.