NCT03657901

Brief Summary

To investigate the efficiency and effect of a programmed slow-breathing exercise in the evening to the heart rate variability, sleep quality and memory performance over night.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

August 29, 2018

Last Update Submit

September 3, 2018

Conditions

StressSleep

Outcome Measures

Primary Outcomes (1)

  • Sleep structure

    Percent distribution of different sleep stages

    Change from night 1 to night 2

Secondary Outcomes (2)

  • Sleep spindle duration

    Change from night 1 to night 2

  • Sleep spindle power

    Change from night 1 to night 2

Study Arms (2)

Breathing

EXPERIMENTAL

Guided slow breathing for 30 minutes before sleep onset

Behavioral: Slow breathing

Music listening

ACTIVE COMPARATOR

Guided music listening for 30 minutes before sleep onset

Behavioral: Music listening

Interventions

Music listeningBEHAVIORAL

Guided music listening for 30 minutes before sleep onset

Music listening
Slow breathingBEHAVIORAL

Guided slow breathing for 30 minutes before sleep onset

Breathing

Eligibility Criteria

Age20 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details10 males, 10 females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-45

You may not qualify if:

  • chronic disease requiring daily medication, acute sickness (e.g. a flu), jet lag from a recent travel, current diagnosed sleep disorder (such as snoring or insomnia) and any use of medication affecting autonomic nervous system function or sleep.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, Finland

Location

Related Links

Study Officials

  • Anu-Katriina Pesonen, prof

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized control trial with a cross-over design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 5, 2018

Study Start

June 1, 2018

Primary Completion

October 30, 2018

Study Completion

December 31, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)