NA NA
Conditions
Interventions
None listed
Sponsors
Netherlands Institute for Neuroscience
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age 18-35 years • Good sleep quality (Pittsburgh Sleep Quality Index <5.1 and Epworth Sleepiness Scale < 11) • Regular sleep-wake patterns • Habitual sleep duration of at least 7 hours per night • Good English language proficiency
Exclusion criteria
Exclusion criteria: • Inability to follow procedures (for example because of insufficient knowledge of project language, cognitive or hearing disturbances etc.) • Individuals with known structural brain lesions • Individuals with a history of seizures or suspected epilepsy • History of a medical condition that may influence sleep and/or brain activity • History or presence of psychological/psychiatric disorders that may affect sleep and/or the ability of the individual to follow experimental procedures • History or presence of a cardiovascular, metabolic or neurological disorder • Individuals with substance abuse (alcohol or other substances) in the last 6 months • Lactating women, or female subjects of child-bearing potential who are pregnant or planning to become pregnant. • Current or recent use of medications with psychotropic effects (e.g. antipsychotics, antidepressants, anxiolytics, psychostimulants, antihistamines or beta blockers - based on individual*s report and/or clinician judgement). • Traveling to time zones with a time difference of more than 1 hour in the 2 weeks preceding the study days • Individuals with extreme chronotypes (30 points or lower, or 70 points or higher on the morningness-eveningness questionnaire) • Presence of snoring • Blood pressure 140/90 mmHg or heart rate < 55 beats per minute • Any medications or conditions contra-indicative of the use or interacting with atomoxetine, clonidine, or donepezil. Including: Medical Conditions • Liver and Kidney Disorders: Liver insufficiency, kidney insufficiency • Cardiovascular Diseases: Severe hypertension, heart failure, arterial occlusive disease, angina pectoris, congenital heart disease (hemodynamically significant), cardiomyopathy, history of myocardial infarction, life-threatening arrhythmias, channelopathies, sick sinus syndrome (brady-tachycardia syndrome), supraventricular conduction disorders (e.g., sino-atrial or atrioventricular block), electrolyte imbalances (hypokalemia, hypomagnesemia), prolonged QT interval (acquired or familial history), cerebrovascular disorders (aneurysm, stroke) • Respiratory Disorders: History of asthma, obstructive pulmonary disease • Neurological and Psychiatric Conditions: Epilepsy, neuroleptic malignant syndrome, psychiatric disorders (e.g., psychosis, depression), polyneuropathy, cerebrovascular or peripheral vascular disorders, autonomic neuropathy (e.g., due to diabetes mellitus) • Gastrointestinal Disorders: Ulcers (or concurrent use of NSAIDs), constipation • Metabolic and Genetic Disorders: Galactose intolerance, lactase deficiency, glucose-galactose malabsorption • Other Conditions: Pheochromocytoma • Hypersensitivity to specific compounds of the medications • Gelatin • Sodium lauryl sulfate (E487) • Titanium dioxide (E171) • Indigotine (E132) • Hydroxypropylmethylcellulose (E464) • Propylene glycol (E1520) • Talc (E553b) • Polyethylene glycol (PEG 6000) • Yellow iron oxide (E172) (for 10 mg formulations) • Donepezil hydrochloride monohydrate • Lactose monohydrate • Microcrystalline cellulose • Dried maize starch • Hydroxypropylcellulose • Sodium stearyl fumarate • Medication Interactions • Cardiovascular Medications: • Class IA antiarrhythmics (e.g., quinidine) • Class III antiarrhythmics (e.g., amiodarone, s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two main study parameters are 1) The topography and amplitude of the evoked and spontaneous type I slow waves measured by EEG in wakefulness, NREM and REM sleep. 2) Number of mental experiences reported and features of the mental experiences (e.g. vividness) assessed with a questionnaire in RedCap. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are 1) Physiological arousal measures, including electrocardiographic (ECG), breathing and skin conductance, pulse wave amplitude. 2) physical arousal measured with EMG. 3) Subjective arousal measures including sleepiness, alertness and subjective perception of sleep quantity and quality during the serial awakenings and falling a sleep period. | — |
Countries
Netherlands
Contacts
Public ContactFSR Siclari
Netherlands Institute for Neuroscience
Outcome results
None listed