Melatonin on sleep architecture in COPD patients
Not Applicable
- Conditions
- Health Condition 1: null- Moderate and severe stable COPD.
- Registration Number
- CTRI/2018/04/013444
- Lead Sponsor
- Artemis Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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
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 <br/ ><br>2) Changes in Hindi Mini Functional Outcome Sleep Questionnaire (FOSQ) <br/ ><br>Timepoint: 1 yr
- Secondary Outcome Measures
Name Time Method Change in modified Hindi Epworth Sleepiness score -1 (ESS-1)Timepoint: 1 yr