Melatonin on sleep architecture in COPD patients

Not yet recruiting

Conditions: Moderate and severe stable COPD.

Registration Number: CTRI/2018/04/013444

Lead Sponsor: Artemis Hospital

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Activity Data (number of steps in a day) before and after Melatonin	1 yr
2) Changes in Hindi Mini Functional Outcome Sleep Questionnaire (FOSQ)	1 yr

Secondary Outcome Measures

Name	Time	Method
Change in modified Hindi Epworth Sleepiness score -1 (ESS-1)	1 yr

Trial Locations

Locations (1): ARTEMIS HOSPITALS
🇮🇳
Gurgaon, HARYANA, India
ARTEMIS HOSPITALS
🇮🇳Gurgaon, HARYANA, India
DR HIMANSHU GARG
Principal investigator
9540156157
drhimgarg@yahoo.com