NCT05846425

Brief Summary

The goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises. The main questions it aims to answer are:

  • Can the memory performance get better ?
  • Can the subjective stress level be reduced ? Participants will complete a memory test while doing a specific nasal and oral breathing. They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group, the are divided into. Researchers will compare the effect of different breathing styles on memory ability among themselves.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

June 3, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 26, 2023

Last Update Submit

April 16, 2024

Conditions

Keywords

Mnemonic similarity taskYoga-breathingMemory enhancement

Outcome Measures

Primary Outcomes (1)

  • Improvement of learned images

    Memory improvement by performing the home nasal breathing training. The correctness of the mapping is measured by the percentage correctness of the given answers in the memory test, which takes place promptly after the learning phase and 2 weeks later.

    2 weeks

Secondary Outcomes (1)

  • Reduction of subjective stress level

    2 weeks

Study Arms (3)

Nose-breathing

EXPERIMENTAL

Controlled nose-breathing

Other: Nose-breathing training

Mouth-breathing

ACTIVE COMPARATOR

Controlled mouth-breathing

Other: Mouth-breathing training

Control group

NO INTERVENTION

no intervention

Interventions

13 days of controlled nose-breathing training at a specific frequency with a duration of approximately 15 min a day

Nose-breathing

13 days of controlled mouth-breathing training at a specific frequency with a duration of approximately 15 min a day

Mouth-breathing

Eligibility Criteria

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

You may qualify if:

  • Willingness to take on the 2-week exercises but no new athletic or meditative activities
  • Yoga-naive and without significant prior experience in various meditative or athletic disciplines that ostensibly involve elements of breath control
  • Access to a device with internet access
  • Signing of the consent form to participate in the study

You may not qualify if:

  • Known clinically relevant internal or neurological diseases, especially if associated with chronic pathological oxygenation (e.g. COPD, severe bronchial asthma, sleep apnea, but also CKD).
  • History of drug or alcohol abuse
  • Known psychiatric illnesses that currently require therapy (e.g., pronounced claustrophobia)
  • Medication that could falsify the data collected
  • Lack of consent to take note of possible incidental findings
  • known epileptic seizures, which could be intensified by the visual insertion of the stimuli

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diagnostic and Interventional Neuroradiology, Saarland University Medical Center

Homburg, Saarland, 66421, Germany

RECRUITING

Related Publications (3)

  • Zelano C, Jiang H, Zhou G, Arora N, Schuele S, Rosenow J, Gottfried JA. Nasal Respiration Entrains Human Limbic Oscillations and Modulates Cognitive Function. J Neurosci. 2016 Dec 7;36(49):12448-12467. doi: 10.1523/JNEUROSCI.2586-16.2016.

    PMID: 27927961BACKGROUND
  • Klippenstein JL, Stark SM, Stark CEL, Bennett IJ. Neural substrates of mnemonic discrimination: A whole-brain fMRI investigation. Brain Behav. 2020 Mar;10(3):e01560. doi: 10.1002/brb3.1560. Epub 2020 Feb 3.

    PMID: 32017430BACKGROUND
  • Stark SM, Kirwan CB, Stark CEL. Mnemonic Similarity Task: A Tool for Assessing Hippocampal Integrity. Trends Cogn Sci. 2019 Nov;23(11):938-951. doi: 10.1016/j.tics.2019.08.003. Epub 2019 Oct 6.

    PMID: 31597601BACKGROUND

MeSH Terms

Conditions

HypoventilationHyperventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Krick, Dr.rer.med.

    University of Saarland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Nose-breathing group, Mouth-breathing group, Control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

June 3, 2023

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations