Healthy
Conditions
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.
Detailed description
In patient with obstructive sleep apnea, studies have shown that respiratory muscle training improved sleep-related outcomes in patients with obstructive sleep apnea (OSA). On the other hand, a recent study showed that expiratory muscle training improved tongue motor strength in patients with OSA. We hypothesize that respiratory muscle training (either Inspiratory Muscle Training (IMT) or Expiratory Muscle Training (EMT)) may elicit sleep-related improvement in patient with OSA through enhancement on tongue muscle function. To investigate our hypothesis, we will first address this question in a population of healthy subjects. This study will therefore investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. The primary hypothesis is that the IMT program with lead to an increase in tongue strength compared to the control group. Other hypothesizes are that EMT, but not sham, will also lead to an increase in tongue strength, compared to the control group.
Interventions
DEVICEIMT
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.
DEVICEEMT
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.
DEVICESham
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.
Sponsors
Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Community ambulant adults between 18 to 65 years old as of testing day; able to understand French or Dutch (depending on the study's site of inclusion); BMI ≥ 18 and ≤ 30 kg/m².
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue elevation strength | Measured two times: at baseline and after 8 weeks | Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tongue elevation endurance | Measured two times: at baseline and after 8 weeks | Tongue elevation endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI). |
| Tongue protrusion endurance | Measured two times: at baseline and after 8 weeks | Tongue protrusion endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI). |
| Maximal inspiratory pressure | Measured two times: at baseline and after 8 weeks | Maximal inspiratory pressure will be measured at functional residual capacity (FRC) |
| Maximal expiratory pressure | Measured two times: at baseline and after 8 weeks | Maximal expiratory pressure will be measured at total lung capacity (TLC) |
| Tongue protrustion strength | Measured two times: at baseline and after 8 weeks | Tongue protrusion strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI). |
| Tongue base thickness | Measured two times: at baseline and after 8 weeks | This measurement will be performed with a portable ultrasound machine |
| Total sagittal thickness | Measured two times: at baseline and after 8 weeks | This measurement will be performed with a portable ultrasound machine |
| Lateral pharyngeal wall thickness | Measured two times: at baseline and after 8 weeks | This measurement will be performed with a portable ultrasound machine |
| Snoring duration | Measured two times: at baseline and after 8 weeks | This recording will be conducted using the standard microphone application installed on the participant's personal phone and through the use of the free, already validated in studies, SnoreLab application. |
| Snoring intensity | Measured two times: at baseline and after 8 weeks | The participants' bed partners (if applicable) will be asked to rate their partner´s snoring using a Visual Analog Scale (VAS), which ranked the impact of snoring from 0 (no snoring) to 10 (intolerable). |
Countries
Belgium, Switzerland
Contacts
Primary ContactWilliam Poncin
Outcome results
None listed