NCT03692962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

June 4, 2018

Last Update Submit

February 10, 2021

Conditions

Sleep Restriction

Outcome Measures

Primary Outcomes (1)

  • risk-premium

    risk-preference (i.e. risk premium assessed with the risk Task as described in Maric et al. 2017 Ann Neurol) after chronic sleep restriction with and without acoustic Stimulation will be quantified by the risk-premium derived from the choices made in the risk-task as described in Maric et al. 2017 Ann Neurol.

    comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation

Secondary Outcomes (11)

  • high-density electroencephalography (hdEEG) marker of sleep pressure

    assessed during first and last sleep restriction nights in comparison to baseline values

  • brain metabolites

    before to after 7 nights of sleep restriction with and without acoustic stimulation

  • vigilance measures

    before to after 7 nights of sleep restriction with and without acoustic stimulation

  • deception willingness

    before to after 7 nights of sleep restriction with and without acoustic stimulation

  • Motor inhibitory control performance

    before to after 7 nights of sleep restriction with and without acoustic stimulation

  • +6 more secondary outcomes

Study Arms (2)

Sleep restriction without acoustic stimulation

SHAM COMPARATOR
Behavioral: Sleep restriction

Sleep restriction with acoustic stimulation

EXPERIMENTAL
Behavioral: Sleep restrictionOther: Acoustic stimulation

Interventions

Sleep restrictionBEHAVIORAL

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

Sleep restriction with acoustic stimulationSleep restriction without acoustic stimulation
Acoustic stimulationOTHER

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

Sleep restriction with acoustic stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Acoustic Stimulation

Intervention Hierarchy (Ancestors)

TherapeuticsSensory Art TherapiesComplementary TherapiesPhysical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 4, 2018

First Posted

October 2, 2018

Study Start

September 1, 2018

Primary Completion

October 12, 2020

Study Completion

November 2, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

CH(1)