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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT06613958
Eligibility Criteria:
Inclusion Criteria:
* Aged between 60 and 80 years old
* Retired
* Long lasting sleep problems (as assessed by a the screening questionnaire administered telephonically and by the ISI which will be filled out during the screening visit)
* Access to and ability to use a smart phone (Android or Apple)
Exclusion Criteria:
* Currently employed or working
* Extreme sleep chronotypes (measured by the Munich chronotype questionnaire)
* Participation in any sort of fasting regimen (e.g. intermitted fasting or Ramadan)
* Experienced recent (\<6 months) adverse life events (e.g., death of partner)
* Abnormal values in glucose metabolism, thyroid, liver or kidney function, or inflammation markers that after examination of the study doctor need immediate attention of a general practitioner or specialist.
* Diagnosed clinical depression
* Diagnosed neurodegenerative diseases (e.g. dementia or Parkinson's disease)
* Diagnosed sleep apnoea
* Diagnosed restless legs syndrome
* Use of beta-adrenergic blocking agents
* Use of sleep medication\*
* Injuries or other severe physical conditions (such as active arthrosis) that inhibits physical activity
* Travelled across time zones one week prior to start of study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT06613958
Study Brief:
Protocol Section:
NCT06613958