Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00869167
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00869167
Study Brief:
Protocol Section:
NCT00869167