Healthy Subjects Clinical Trial
— SleepD-ISOOfficial title:
Infra-slow Oscillations During Sleep, After Acute Sleep Deprivation and in Subjects With Restless Legs Syndrome/Periodic Leg Movements During Sleep (RLS/PLMS): an Explorative, Prospective, Monocentric, Observational Case-control and Interventional Study
Verified date | August 2018 |
Source | Neurocenter of Southern Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study the investigators plan to systematically characterise infra-slow EEG oscillations during sleep, explore their relationship to the microstructure of sleep, and investigate its role in the physiology and pathophysiology of sleep by co-registration of Full band EEG with polysomnography during wake and sleep in healthy subjects, after sleep deprivation, and in patients with restless legs syndrome/periodic leg movements during sleep (RLS/PLMS).
Status | Completed |
Enrollment | 18 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria for all participants: - Willingness to participate and written informed consent - Aged 20 to 40 years at the time of screening - Body mass index (BMI) = 30 Additional inclusion criteria for subjects with RLS/PLMS: - Either diagnosis of RLS and current IRLS score = 15. - Or frequent periodic leg movements during sleep Exclusion criteria for all participants: - Pregnancy or breast feeding at the time of screening - Sleep related breathing disorders - Current psychiatric disorders - Current chronic treatment that may affect sleep. - Any significant neurological disorder or other medical disease that may affect sleep. - Any unstable medical condition. Additional exclusion criteria for participants with RLS/PLMS: - Current intake of dopaminergic drugs - Current intake of other RLS relevant medication - Intake of hypnotics - Other significant sleep disorder except symptoms potentially related to RLS Additional exclusion criteria for healthy participants: - Any pharmacological treatment that may affect sleep and/or sleep related movement disorders - Any clinically significant sleep disorders |
Country | Name | City | State |
---|---|---|---|
Switzerland | Neurocenter of Southern Switzerland | Lugano | Ticino |
Lead Sponsor | Collaborator |
---|---|
Stephany Fulda |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infra-slow frequency power | Average power (µV) in the infra-slow frequency range during wake and different stages of sleep derived from standard fast fourier transform and continuous wavelet transform. | 36 hours |
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