chronic insomnia in COPD patients Insomnia, COPD, Lemborexant
Conditions
Interventions
lemborexant (5mg) 1 tab po od hs,placebo 1 tab po od hs
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Ratchadaphiseksomphot Endowment Fund
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: Male and female patients aged 45 to 80 years Patients diagnosed with Chronic Obstructive Pulmonary Disease according to the GOLD Guideline, who are followed up at the pulmonary outpatient clinic, including all severity levels Patients diagnosed with COPD in a stable condition at the time of enrollment Patients who meet the diagnostic criteria for chronic insomnia according to the ICSD3TR, with an Insomnia Severity Index (ISI) score more than8 Patients who have undergone an evaluation of COPD severity with pulmonary function testing results available within the past 1 year
Exclusion criteria
Exclusion criteria: Patients who are unable to read, write, or understand the questionnaires by themselves Patients with other medical conditions that affect sleep, such as chronic neuropathic pain, severe heart failure, nocturia more than 4 times per night, chronic kidney disease stage 4 or higher, or liver cirrhosis (Child-Pugh Class C). Patients with alcohol dependence or substance abuse Patients with other sleep disorders, such as suspected obstructive sleep apnea , restless legs syndrome , or narcolepsy Patients already diagnosed with these disorders will be excluded Patients without prior diagnosis will be screened using the STOP-BANG questionnaire; those scoring more than 5 will be excluded Patients who have taken sedative medications or sleeping pills within 2 weeks before study entry Patients with respiratory tract infections within the past 30 days Patients working in shift-based occupations, such as medical personnel, security guards, or factory workers Patients taking medications with drug interactions with lemborexant, such as itraconazole, clarithromycin, fluconazole, verapamil, rifampicin, carbamazepine, bosentan, efavirenz, etc. Other potential interactions will be reviewed by the investigators Patients with psychiatric disorders, including depression or anxiety disorders: Those previously diagnosed by a psychiatrist will be excluded For undiagnosed individuals, screening will be done using: PHQ-9: Score more than 5 excluded. GAD-7: Score more than 10 excluded. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insomnia at 30days after end of the intervention insomnia severity index | — |
Secondary
| Measure | Time frame |
|---|---|
| dypsnea at 30days after end of the intervention CAT score | — |
Countries
Thailand
Contacts
Public ContactSirapat Thanasapampai
KCMH
Outcome results
None listed