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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05565833
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 65 years of age.
* Able to speak and read English, and is a US resident.
* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
* Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
* The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months.
* Cognitive impairment through study assessment.
* Stable medication regimen unless medication is known to cause insomnia
Exclusion Criteria:
* Current psychological treatment for insomnia
* Initiation of psychological or psychiatric treatment within the past three months
* Current diagnosis of Huntington's or Parkinson's disease
* Current treatment for hyperthyroidism
* Currently undergoing chemotherapy
* Presence of asthma or respiratory concerns with night treatment
* Chronic pain treated with opioids
* Not recovered from a brain tumor, injury, or infection
* Epilepsy without stable treatment for at least 3 months
* Irregular sleep schedule
* Use of stimulating medications after 5pm or taken for less than 3 months
* Psychotic or bipolar disorder
* Moderate to high risk of suicide
* Alcohol or drug abuse within the past year
* Other untreated sleep disorders (e.g., obstructive sleep apnea)
* Study screen for severe depression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05565833
Study Brief:
Protocol Section:
NCT05565833