SnoringNCT02834767
Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
A study testing Genioglossis Strength Trainer in people with Snoring and Sleep Apnea, Obstructive, run by University of Florida at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Snoring, Sleep Apnea, Obstructive
- What is being tested?
- Genioglossis Strength Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 4 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Snoring + AHI < 5/hr (primary snoring group)
- AHI ≥ 5/hour and less than 30/hour (OSA group)
- Ability to understand and perform training.
- Ability to return to the UF Health Sleep Center 1X per week for the (8 week) duration of the study.
Who cannot join
- Pregnancy
- Prior Upper airway surgery (nasal surgery is allowed)
- Severe nasal obstruction
- BMI > 40 kg/M2
- Use of CPAP > 12 cm H2O *
- Use of potent narcotics
Show all 12Show fewer
- History of arrhythmia (other than PACs and PVCs)
- Coronary artery disease or congestive heart failure (patients with controlled hypertension will be included),
- Moderate to severe lung disease
- History of pneumothorax.
- severe daytime sleepiness (falling asleep while driving or Epworth Sleepiness Scale > 14),
- History of chronic short sleep duration (< 5 hours).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Sleep Center
Gainesville, Florida, 32606
About this study
Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. The proposed investigation will examine the effects of eight weeks of genioglossus muscle strength training on measures of snoring and OSA severity as well as genioglossus protrusive muscle strength.
Read the detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. The genioglossus (GG, tongue) muscle plays an important role in maintaining upper airway patency. The GG is responsible for tongue protrusion and stiffens the tongue and prevents posterior tongue displacement and upper airway closure. The GG is a phasic respiratory muscle. One can demonstrate inspiratory bursts in GG EMG activity slightly preceding the onset of inspiratory activity of respiratory pump muscles. The inspiratory bursts of GG activity also increase in response to negative pressure in the upper airway to help maintain upper airway patency. In some OSA patients this response is blunted. While one study did not find a difference in protrusion muscle strength between a group of OSA patients (apnea hypopnea index, AHI = 20/hour) and normal controls (Mortimore et al) there was wide variability in muscle strength at similar AHI values. Another study (Oh et al) did find a correlation between tongue protrusion strength and the apnea index (lower strength, higher apnea index). It is hypothesized that strength training of the GG will reduce snoring and sleep apneas by augmenting the resting GG tone and enhancing the ability of the muscle to respond to negative upper airway pressure. Training of upper airway muscles including the tongue is often used in rehabilitation of patients with prior cerebrovascular accidents or damage due to surgical resection for cancer. Typically, the patient presses the tongue against the back of the upper teeth (direction both upward and forward). However, it is believed that tongue protrusion is best trained by active forward protrusion of the tongue between the teeth under load. To facilitate GGs training participants will push a spring loaded piston forward with the tongue. The piston fits inside an outer chamber. The piston can also be connected to a force measuring device to estimate protrusive tongue force.
Two groups of participants will be examined: Group 1: primary snoring and Group 2: mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 40 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. This preliminary investigation consists of a randomized controlled trial (training versus sham training) with two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of training maneuvers and meet with them weekly to observe the subject's technique and measure tongue strength. A training log will be kept by the subjects using training schedule sheets and training will be directly monitored at least 2 times weekly through with a study clinician (electronically via facetime, skype or by direct observation).
- Conditions
- Snoring, Sleep Apnea, Obstructive
- Being tested
- Genioglossis Strength Trainer, Placebo Genioglossis Strength Trainer
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genioglossis Strength TrainerDevice
Also called Tongue Strength Trainer
The genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. The device can be set to a specific pressure resistance ranging from 10 to 40 Newtons. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).
Placebo Genioglossis Strength TrainerDevice
Also called Placebo Tongue Strength Trainer
The placebo genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. Whereas the pressure loaded spring in the active trainer can be set to a wide range of pressures, the placebo trainer has a maximum resistance of 5 Newtons. The device is set to a specific pressure resistance of 5 Newtons at all times. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Primary Snoring Treatment | Experimental | Intervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. Receives: Device: Genioglossis Strength Trainer |
| Group 2 Primary Snoring Placebo | Placebo comparator | Intervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. Receives: Device: Placebo Genioglossis Strength Trainer |
| Group 3 Primary OSA Treatment | Experimental | Intervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. Receives: Device: Genioglossis Strength Trainer |
| Group 4 Primary OSA Placebo | Placebo comparator | Intervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. Receives: Device: Placebo Genioglossis Strength Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tongue Pressure Force (MTPF)
Maximum pressure generated (in Newtons) during tongue protrusion
Measured: Pre to post treatment (approximately 10 weeks)
Secondary outcomes (2)
Snoring Severity
Snoring sensor recording snoring frequency and amplitude during sleep
Measured: Pre to post treatment (approximately 10 weeks)
Apnea-Hypopnea Index
Episodes of apnea and/or hypopnea scored during the course of sleep study
Measured: Pre to post treatment (approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion4 May 2019
- Study completion4 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Berry, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834767
- Sponsor's protocol ID
- IRB201600916
- Status last verified
- Feb 2020
- First submitted
- 13 Jul 2016
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02834767
- Acronym / sponsor ID
- IRB201600916
- Conditions
- Snoring, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 4 May 2019 (actual)
- Study completion
- 4 May 2019 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. The proposed investigation will examine the effects of eight weeks of genioglossus muscle strength training on measures of snoring and OSA severity as well as genioglossus protrusive muscle strength.
Detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. The genioglossus (GG, tongue) muscle plays an important role in maintaining upper airway patency. The GG is responsible for tongue protrusion and stiffens the tongue and prevents posterior tongue displacement and upper airway closure. The GG is a phasic respiratory muscle. One can demonstrate inspiratory bursts in GG EMG activity slightly preceding the onset of inspiratory activity of respiratory pump muscles. The inspiratory bursts of GG activity also increase in response to negative pressure in the upper airway to help maintain upper airway patency. In some OSA patients this response is blunted. While one study did not find a difference in protrusion muscle strength between a group of OSA patients (apnea hypopnea index, AHI = 20/hour) and normal controls (Mortimore et al) there was wide variability in muscle strength at similar AHI values. Another study (Oh et al) did find a correlation between tongue protrusion strength and the apnea index (lower strength, higher apnea index). It is hypothesized that strength training of the GG will reduce snoring and sleep apneas by augmenting the resting GG tone and enhancing the ability of the muscle to respond to negative upper airway pressure. Training of upper airway muscles including the tongue is often used in rehabilitation of patients with prior cerebrovascular accidents or damage due to surgical resection for cancer. Typically, the patient presses the tongue against the back of the upper teeth (direction both upward and forward). However, it is believed that tongue protrusion is best trained by active forward protrusion of the tongue between the teeth under load. To facilitate GGs training participants will push a spring loaded piston forward with the tongue. The piston fits inside an outer chamber. The piston can also be connected to a force measuring device to estimate protrusive tongue force.
Two groups of participants will be examined: Group 1: primary snoring and Group 2: mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 40 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. This preliminary investigation consists of a randomized controlled trial (training versus sham training) with two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of training maneuvers and meet with them weekly to observe the subject's technique and measure tongue strength. A training log will be kept by the subjects using training schedule sheets and training will be directly monitored at least 2 times weekly through with a study clinician (electronically via facetime, skype or by direct observation).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Primary Snoring Treatment | Experimental | Device: Genioglossis Strength TrainerIntervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. |
| Group 2 Primary Snoring Placebo | Placebo comparator | Device: Placebo Genioglossis Strength TrainerIntervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. |
| Group 3 Primary OSA Treatment | Experimental | Device: Genioglossis Strength TrainerIntervention: Eight weeks of supervised use of the genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. |
| Group 4 Primary OSA Placebo | Placebo comparator | Device: Placebo Genioglossis Strength TrainerIntervention: Eight weeks of supervised use of the placebo genioglossus muscle strength trainer. Training will occur 5 days per week for 8 weeks. Each daily training regimen to consist of 5 sets of 5 repetitions (25 repetitions total daily) of tongue contractions using the device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Snoring + AHI < 5/hr (primary snoring group)
- AHI ≥ 5/hour and less than 30/hour (OSA group)
- Ability to understand and perform training.
- Ability to return to the UF Health Sleep Center 1X per week for the (8 week) duration of the study.
Key exclusion criteria (12 listed)
- Pregnancy
- Prior Upper airway surgery (nasal surgery is allowed)
- Severe nasal obstruction
- BMI > 40 kg/M2
- Use of CPAP > 12 cm H2O *
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genioglossis Strength TrainerAlso: Tongue Strength TrainerThe genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. The device can be set to a specific pressure resistance ranging from 10 to 40 Newtons. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter). | Device | Group 1 Primary Snoring Treatment, Group 3 Primary OSA Treatment |
| Placebo Genioglossis Strength TrainerAlso: Placebo Tongue Strength TrainerThe placebo genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. Whereas the pressure loaded spring in the active trainer can be set to a wide range of pressures, the placebo trainer has a maximum resistance of 5 Newtons. The device is set to a specific pressure resistance of 5 Newtons at all times. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter). | Device | Group 2 Primary Snoring Placebo, Group 4 Primary OSA Placebo |
Primary outcome
Maximum Tongue Pressure Force (MTPF)
Time frame: Pre to post treatment (approximately 10 weeks)
Maximum pressure generated (in Newtons) during tongue protrusion
2 secondary outcomes
Snoring Severity
Time frame: Pre to post treatment (approximately 10 weeks)
Apnea-Hypopnea Index
Time frame: Pre to post treatment (approximately 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Berry, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genioglossis Strength Trainer in people with Snoring and Sleep Apnea, Obstructive, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tongue Pressure Force (MTPF) (time frame: Pre to post treatment (approximately 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.