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Effects of low-frequency magnetic fields on sleep and markers of Alzheimer's disease in humans

Not Applicable
Recruiting
Conditions
Healthy volunteers
Registration Number
DRKS00029254
Lead Sponsor
Bundesamt für Strahlenschutz
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

• Current physical and mental health
• Postmenopausal women (last menstruation one year ago)
• No or stable internal medication
• Currently no sleep disorder according to the International Classification of Sleep Disorders (ICSD 3; American Academy of Sleep Medicine, AASM, 2014)
• Regular sleep-wake cycle (sleep diary)
• Right-handedness
• Non-smoker

Exclusion Criteria

• Use of hypnotics
• Excessive consumption of substances that affect the central nervous system (including caffeinated drinks, alcohol, drugs)
• Working on night shift (22:00 to 06:00)
• Electronic or electrically conductive implants
• Piercings or non-removable metal body jewelry
• scores above cut-off in the Montreal Cognitive Assessment (MoCa, Nasreddine et al., 2005)
• scores above cut-off ??in screening questionnaires on sleep and health

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary endpoints are the sleep macrostructure and the objective sleep efficiency, as well as the Alzheimer-associated biomarkers Aß40/42 and tau proteins. The sleep parameters are recorded every night in the sleep laboratory (one night per exposure condition), the biomarkers are determined by taking a blood sample before and after every sleep recording in the sleep laboratory.
Secondary Outcome Measures
NameTimeMethod
The secondary endpoints are memory performance in the declarative and procedural memory test as well as the parameters for the subjective sleep quality derived from the evening-morning protocol and possible physical symptoms. These endpoints are also collected before and after each sleep recording in the sleep laboratory.
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