NCT06627283

Brief Summary

This study aims to investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. We hypothesize that respiratory muscle training can improve strength and endurance of the tongue muscles.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
2mo left

Started Nov 2024

Typical duration for not_applicable healthy

Geographic Reach
2 countries

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2024Jul 2026

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

October 2, 2024

Last Update Submit

April 28, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Tongue elevation strength

    Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).

    Measured two times: at baseline and after 8 weeks

Secondary Outcomes (10)

  • Tongue protrustion strength

    Measured two times: at baseline and after 8 weeks

  • Tongue elevation endurance

    Measured two times: at baseline and after 8 weeks

  • Tongue protrusion endurance

    Measured two times: at baseline and after 8 weeks

  • Maximal inspiratory pressure

    Measured two times: at baseline and after 8 weeks

  • Maximal expiratory pressure

    Measured two times: at baseline and after 8 weeks

  • +5 more secondary outcomes

Study Arms (4)

IMT

ACTIVE COMPARATOR
Device: IMT

EMT

ACTIVE COMPARATOR
Device: EMT

Sham

SHAM COMPARATOR
Device: Sham

Control

NO INTERVENTION

Interventions

IMTDEVICE

Description: A pressure threshold loading device will be used: the POWERbreathe Medic (load range 10-90 cmH2O). Participants will be instructed to exhale passively during normal tidal breathing through the training device (until functional residual capacity) and to perform deep inspirations against the external load. The first week, the resistance will be fixed at 30% of the baseline measured maximal inspiratory pressure (MIP). Participants will be instructed to increase the resistance by 10% of the baseline set resistance each week.

IMT
EMTDEVICE

A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic (load range 10-90 cmH2O) or POWERbreathe Ex1 EMT MR (load range 35-175 cmH2O) depending on their baseline MEP measurement. Participants will be instructed to inhale quietly during normal tidal breathing through the training device and to perform rapid and deep exhalation against the external load. The first week, the resistance will be fixed at 30% of the baseline measured MEP. Participants will be instructed to increase the resistance by 10% of the baseline set resistance each week.

EMT
ShamDEVICE

A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic or MR, but with the resistance mechanism inside removed and replaced by a plastic ball. The same instructions will be given as for the EMT group, except that there will be no or minimal resistance (less than 6 cmH2O). There will be no change in resistance over the weeks.

Sham

Eligibility Criteria

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

You may not qualify if:

  • Any diagnosed neuromuscular or cardiorespiratory disease; diagnosed psychiatric or psychological disorders which could affect adherence to or comprehension of instructions; diagnosed eating disorders; previous or ongoing head and neck cancer; diagnosed OSA; presenting a high-risk of sleep-disordered breathing indicated by a NoSAS score of 8 or higher 32 or a STOP-Bang score of 3 or higher 33,34; resting heart rate (HR) \> 100 beats per minute (bpm) or \< 50 bpm; resting systolic blood pressure (SBP) \> 140 or \< 90 mmHg, diastolic blood pressure (DBP) \> 90 or \< 50 mmHg; oxygen saturation (SpO2) \< 94% at rest on room air. Individuals with abnormal lung function, i.e., forced expiratory volume in 1 second (FEV1) ≤ 80%, forced vital capacity (FVC) ≤ 80%, and FEV1/FVC ≤ 70%, will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KULeuven

Leuven, 3000, Belgium

RECRUITING

UCLouvain

Louvain-la-Neuve, 1348, Belgium

RECRUITING

HESAV

Lausanne, 1011, Switzerland

RECRUITING

Central Study Contacts

William Poncin

CONTACT

+3227642316william.poncin@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

November 4, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)CH(1)