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Feasibility study using Stellar i-ris to predict fatigue and substance abuse in healthy subjects

Feasibility study using Stellar i-ris to predict fatigue and substance abuse in healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025440
Enrollment
50
Registered
2021-11-03
Start date
2019-09-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Group 1: Participants (n = 50). In a repeated-measures design, the pupillary light reflex of each subject is measured at 4 study visits: T0: Baseline measurement. T1: Measurement after 24h sleep depr

Sponsors

Stellar DBS GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 68 Years

Inclusion criteria

Inclusion criteria: Healthy participants of ages between 18 und 68 years.

Exclusion criteria

Exclusion criteria: Epilepsy, neurological diseases (e.g. appoplexy, cerebral hemorrhage, neurodegenerative diseases). Severe eye disease (e.g. glaucoma, retinal detachment, pupillary motor disorder). Mental illness. Metabolic diseases. Medication that affects the pupillary motor function and the sympathetic or parasympathetic nervous system. Medication that affects the ability to concentrate (e.g. painkillers from level II according to WHO). Drug/alcohol abuse. Visible head injuries or diseases in the area of the head. Artificial eye lenses or absence of an eye lens. To ensure optimal concentration, participants should also refrain from drinking excessive amounts of coffee or tea for 24 hours prior to testing, as well as do not engage in extreme sports.

Design outcomes

Primary

MeasureTime frame
The aim is to show that the pupillary light reflex parameters exhibit a condition-specific pattern in the 3 stages of the repeated-measures design (control condition, alcohol ingestion, sleep deprivation). The 4th test of the diurnal profiles is designed to determine the background noise that occurs within a subject over the course of a day.

Secondary

MeasureTime frame
Acceptance of measurement.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026