| CTRI Number |
CTRI/2018/04/013444 [Registered on: 24/04/2018] Trial Registered Prospectively |
| Last Modified On: |
17/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Melatonin on sleep architecture in COPD patients |
|
Scientific Title of Study
|
A Pilot study to assess the effect of melatonin on sleep and daily activity in patients with Stable COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Garg |
| Designation |
Head, Department of Respiratory Critical Care Sleep Medicine |
| Affiliation |
Artemis Hospital |
| Address |
Artemis Hospital
Respiratory Critical Care Sleep Medicine
Ground Floor, Room No-1017,
Sector 51
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9540156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Garg |
| Designation |
HOD, RESPIRATORY AND SLEEP MEDICINE |
| Affiliation |
ARTEMIS HOSPITALS |
| Address |
rESPIRATORY AND CRITICAL CARE SLEEP MEDICINE
GROUND FLOOR, ROOM No-1017,ARTEMIS HOSPITALS
SECTOR 51
GURGAON
Gurgaon
HARYANA
122001
India |
| Phone |
9540156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Garg |
| Designation |
Head, Department of Respiratory Critical Care Sleep Medicine |
| Affiliation |
Artemis HospitalL |
| Address |
Artemis Hospital
Respiratory Critical Care Sleep Medicine
Ground Floor, Room No-1017,
Sector 51
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9540156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ARTEMIS HOSPITALS
SECTOR 51
GURGAON-122001
HARYANA |
|
|
Primary Sponsor
|
| Name |
Artemis Hospital |
| Address |
Sector 51, Gurgaon-122001
Haryana |
| 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 HIMANSHU GARG |
ARTEMIS HOSPITALS |
ARTEMIS HOSPITAL
DEPARTMENT OF RESPIRATORY CRITICAL CARE SLEEP MEDICINE,
GROUND FLOOR,
ROOM NO- 1017,
SECTOR 51, GURGAON
Gurgaon
HARYANA |
9540156157
drhimgarg@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Moderate and severe stable COPD., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The IP Melatonin 3 mg that means N-acetyl-5-methoxy tryptamine (5 mg) tablet will be used in this study. |
3 mg IP will be advised after the baseline visit.The drug would be used for 4 wks.
This drug is used for sleep disorder. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with or without smoking history along with the diagnosis of moderate to severe COPD along with the treatment of LABA/LAMA or LABA/ICS and LAMA
2.Patients who have not had an exacerbation of COPD for at least 6 wks
3. Willing to give consent |
|
| ExclusionCriteria |
| Details |
1.Concurrent Obstructive Sleep Apnoea
2.Heart failure
3.Uncontrolled diabetes
4.Primary insomnia
5.Any other pulmonary disease
6.Patients who exacerbate during study
participation
7.Patients on Long term Oxygen therapy
8.Patients who are on BIPAP/CPAP
9.Patients who are on Sleeping medications (hypnotics/opioids, pain killers-pregabalin etc) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Activity Data (number of steps in a day) before and after Melatonin
2) Changes in Hindi Mini Functional Outcome Sleep Questionnaire (FOSQ)
|
1 yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in modified Hindi Epworth Sleepiness score -1 (ESS-1) |
1 yr |
|
|
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)
|
26/04/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is being conducted to assess the effect of 3mg melatonin in improving sleep quality and daytime activity in stable moderate and severe COPD. Many patients of COPD have fragmented sleep, trouble falling asleep, staying asleep, waking during the night and waking up feeling tired. These patients may also have poorer functional outcomes (higher prevalence of wheezing, mucus production and a higher frequency of exacerbations). Thus, we wish to know if administration of Melatonin (which is a hormone produced by the pineal gland and regulates sleep and wakefulness) will improve the sleep architecture in these patients. . The data collected in this study will help us to evaluate the effect of 3mg melatonin on sleep architecture in patients with moderate |