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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03823105
Eligibility Criteria:
Patients with sleep wake disorders
Inclusion Criteria:
* 18 ≤ Age ≤ 80 years
* Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
* Written informed consent
Exclusion Criteria:
* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist
Healthy subjects
Inclusion criteria:
* 18 ≤ Age ≤ 80 years
* Written informed consent
Exclusion criteria:
* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Any Medication (except birth control pill)
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Implanted devices (e.g. pacemaker, pumps)
* Known sleep-wake disorders
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03823105
Study Brief:
Protocol Section:
NCT03823105