Healthy volunteers
Conditions
Interventions
Group 1: Sham exposure (during the entire 8hr sleep recording in the laboratory
one night/participant)
Group 2: Magnetic field with lower flux density (in the range from 1 to 5µT
(during the entire 8hr sleep recording in the laboratory
one night/participant)
Group 3: Magnetic field with higher flux density (in the range up to 30µT
one night/participant)
Sponsors
Bundesamt für Strahlenschutz
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed