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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05067569
Eligibility Criteria:
Inclusion Criteria:
1. Older adults aged ≥ 60 years
2. Able to give informed online consent
3. Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app
Exclusion Criteria:
1. Shift-workers
2. Travel to a destination with \>2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (\>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05067569
Study Brief:
Protocol Section:
NCT05067569