NCT04276064

Brief Summary

Sleep is ubiquitous in animals and humans, and disruptions are of high clinical importance. Still, the neural basis of sleep perception is insufficiently understood, which limits the development of new treatments. The current project is designed to further contribute to the understanding of the neural basis of sleep perception and to the development of innovative treatments for disrupted sleep (insomnia).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

March 4, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

February 17, 2020

Last Update Submit

March 1, 2024

Conditions

SleepInsomnia

Outcome Measures

Primary Outcomes (1)

  • Modulation Index

    Measure of phase-amplitude coupling

    Averaged across NREM sleep of the baseline night (about 6 hours)

Study Arms (2)

Patients with insomnia

EXPERIMENTAL

Patients with insomnia disorder according to DSM-5 criteria

Device: Auditory closed-loop stimulation: slow oscillation boostingDevice: Auditory closed-loop stimulation: slow oscillation disruptionDevice: Sham stimulation

Healthy controls

EXPERIMENTAL

Healthy controls

Device: Auditory closed-loop stimulation: slow oscillation boostingDevice: Auditory closed-loop stimulation: slow oscillation disruptionDevice: Sham stimulation

Interventions

Auditory closed-loop stimulation: slow oscillation boostingDEVICE

Auditory-closed loop stimulation: slow oscillation boosting

Healthy controlsPatients with insomnia
Auditory closed-loop stimulation: slow oscillation disruptionDEVICE

Auditory closed-loop stimulation: slow oscillation disruption

Healthy controlsPatients with insomnia
Sham stimulationDEVICE

Sham stimulation

Healthy controlsPatients with insomnia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
  • Age 18 to 65 years
  • Written informed consent

You may not qualify if:

  • Relevant current or past serious medical disorder, including but not limited to cardiac arrhythmia, diabetes mellitus, and chronic pain conditions.
  • Neurological conditions including epilepsy, history of brain injury, encephalitis or any organic brain syndrome
  • Current or past mental disorders (life time prevalence), e.g. depressive disorder, attention deficit disorder, psychotic disorders, anxiety disorder, posttraumatic stress disorder
  • Sleep disorders (except ID for patients), including movement-related sleep disorders (PLMS index with arousal \> 5) or breathing-related sleep disorders (AHI \> 15)
  • Intake of CNS active medication (except appropriate thyroid hormone substitution)
  • Current or past substance abuse or dependency
  • Smoking \> 5 cigarettes per day
  • Excessive caffeine consumption (\> 500 mg or 5 cups coffee per day)
  • Irregular sleep schedules resulting from shift work, travelling or personal habits, defined as a sleep/wake time deviation \> 4 hours in the weekly routine or as a habitual total sleep time \< 4.5 hours or \> 10 hours per night
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, Switzerland

Location

Related Publications (1)

  • Mikutta C, Feige B, Maier JG, Hertenstein E, Holz J, Riemann D, Nissen C. Phase-amplitude coupling of sleep slow oscillatory and spindle activity correlates with overnight memory consolidation. J Sleep Res. 2019 Dec;28(6):e12835. doi: 10.1111/jsr.12835. Epub 2019 Mar 7.

    PMID: 30848042BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Christoph Nissen, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

November 1, 2021

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

March 4, 2024

Record last verified: 2024-03

Locations

CH(1)