Ramelteon for Insomnia Comorbid With Asthma

Northwestern University1 site in 1 country2 target enrollmentMarch 2008

ConditionsInsomnia Asthma

InterventionsRamelteon

DrugsRamelteon

Overview

Phase: Phase 3
Intervention: Ramelteon
Conditions: Insomnia
Sponsor: Northwestern University
Enrollment: 2
Locations: 1
Primary Endpoint: Pittsburgh Sleep Quality Index
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Detailed Description

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Brandon Lu

Physician

Northwestern University

Eligibility Criteria

Inclusion Criteria

•Ages 18 - 60 with both insomnia and asthma.
•Insomnia:
•a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,
•the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and
•at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.
•Additional inclusion criteria include: a subjective TST \<6.5 h and a subjective SL \> 45 min per night; a mean LPS \>20 min over 2 consecutive nights by polysomnography (neither night could have been \<15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score \> 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.
•Asthma will be diagnosed based on suggestive clinical history and either
•airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less
•bronchodilator-responsive expiratory airflow limitation (if FEV1 \< 70% of predicted value or \< 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score \< 1.5.

Exclusion Criteria

•Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI \> 15), periodic leg movements (movement arousal index \> 15), REM behavior disorder; or circadian sleep-wake disorders
•History of cognitive or other neurological disorders;
•History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
•Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
•Unstable or serious medical conditions;
•Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
•Shift work or other types of self imposed irregular sleep schedules;
•Obesity (BMI \> 35 Kg/m2); or
•Pregnancy or desire to become pregnant during the study.

Arms & Interventions

1: Ramelteon

Intervention: Ramelteon

2: Placebo

Intervention: Ramelteon

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index

Time Frame: baseline and post-treatment (at end of 5 weeks)

The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

Insomnia Severity Index

Time Frame: 5 weeks

Secondary Outcomes

Daytime Sleepiness (Epworth Sleepiness Scale)(baseline and post-treatment (at end of 5 weeks))
Daytime Performance (Digit Symbol Substitution Test)(baseline and post-treatment (at end of 5 weeks))
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min(baseline and during treatment period (during 5th week))