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What is the attainability of a study examining the stress-reducing effect of a new neurofeedback device?

What is the attainability of a study examining the stress-reducing effect of a new neurofeedback device? - stressreduction by a new neurofeedback device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31743
Enrollment
30
Registered
2008-01-22
Start date
2008-02-13
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Het heeft niet betrekking op mensen met een aandoening: gezonde vrijwilligers die meer dan gemiddeld gestresst zijn maar verder gezond, zijn de doelgroep Healthy volunteers

Interventions

Subjects receive 16 sessions of neurofeedback training of 40 minutes each. During NFT, Subject will be placed in a chair in supine position by the assistant in a dimly lit room. The subject is conne

Sponsors

Philips Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) A score of at least 1 standard deviation above the reported mean of the Perceived Stress Questionnaire 2) 18 - 30 years old 3) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Evidence of a significant psychiatric (e.g. sleep disorder or major depression), neurological (e.g. epilepsy) or other medical (particularly cardiovascular and adrenocortical) disorder at the time of inclusion 2) Pregnancy at the time of inclusion (based on the subjective report of the subject) 3) The excessive use of medication, particularly corticosteroid medication at the time of inclusion 4) Significant alcohol abuse at the time of inclusion 5) An education level that is lower than high school 6) With occurrence of certain medical diseases (for example fever) a subject can be temporarily be excluded from the intervention

Design outcomes

Primary

MeasureTime frame
The primary objective is to investigate stress, sleep, cognitive function and mood in a group of more than average stressed healthy subjects undergoing an 8 week NeuroCARE NFT program or a placebo program. The following assessments will be performed: (1) Assessment of stress * Objective stress level, measured by Heart Rate Variability (standarddeviation of RR-intervalls and intensity of the HF component of the ECG spectrum will be analyzed) * Subjective stress level, measured by POMS short form and a stress rating scale (2) Assessment of sleep * Objective sleep-assessment with SenseWear PRO2 Body Monitoring System * Subjective sleep-assessments with a sleep log and a Dutch translation of the Karolinksa Sleepiness Scale (KSS) (3) Mood Measured by POMS short form (4) Cognitive function Measures of: * declarative long term memory (CVLT) * selective attention (D2 concentration test) * working memory (calculations, Digit Symbol - Coding WAIS III) * executive function (Stroop Colour Word Test, Letter Fluency test)

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)