Decision-making After Sleep Restriction

NCT ID: NCT03692962

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-11-02

Brief Summary

The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.

Conditions

Sleep Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Sleep restriction without acoustic stimulation

Group Type: SHAM_COMPARATOR

Sleep restriction

Intervention Type: BEHAVIORAL

Time in bed will be restricted to 5 hours per night for 7 nights.

Sleep restriction with acoustic stimulation

Group Type: EXPERIMENTAL

Sleep restriction

Intervention Type: BEHAVIORAL

Time in bed will be restricted to 5 hours per night for 7 nights.

Acoustic stimulation

Intervention Type: OTHER

Brief tones will be presented time-locked to ongoing slow waves during deep sleep.

Interventions

Sleep restriction

Time in bed will be restricted to 5 hours per night for 7 nights.

Intervention Type: BEHAVIORAL

Acoustic stimulation

Brief tones will be presented time-locked to ongoing slow waves during deep sleep.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18-21 years or 26-30 years,
• Right-handedness,
• Good general health,
• Good understanding of German language (as all information is provided in German)
• Signed Informed Consent after being informed.

Exclusion Criteria

• Contraindications on ethical grounds,
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
• Known or suspected non-compliance, drug or alcohol abuse (> 5dl wine/ >1l beer daily),
• Regular medication intake,
• Enrolment into a clinical trial within last 4 weeks,
• Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
• Sleep disorders (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.),
• Sleep complaints in general or excessive daytime sleepiness (Pittsburgh Sleep Quality Index > 5; Epworth Sleepiness Scale ≥ 11),
• Irregular sleep-wake rhythm (e.g. shift working),
• Long (> 10 hours per night) or short sleepers (< 7 hours per night),
• Sleep efficiency < 80% in screening night,
• Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to or during the study),
• > 5 drinks or food items containing caffeine per day,
• > 5 cigarettes per day,
• Body Mass Index < 19 or > 30 kg/m2,
• Skin allergy or very sensitive skin
• Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision-making).
• Red-Green Colour-Blindness (as the Risk Task requires the distinction between red and green),
• History of claustrophobia,
• Known hearing disorder (as acoustic stimuli will be applied during sleep),
• Magnetic Resonance (MR) contraindication (such as pacemaker, implanted pumps, shrapnel, etc.; full MR Screening form will be filled out).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology in Zurich (ETH Zurich)

UNKNOWN

Sponsor Role: collaborator

Christian Baumann

OTHER

Sponsor Role: lead

Responsible Party

Christian Baumann

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

DM-SR

Identifier Type: -

Identifier Source: org_study_id