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The Effects of Upper Airway Muscle Training on Obstructive Sleep Apnoea (OSA) Severity and Upper Airway Physiology

The Effects of Upper Airway Muscle Training on Obstructive Sleep Apnoea (OSA) Severity and Upper Airway Physiology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000818932
Enrollment
7
Registered
2020-08-17
Start date
2020-06-22
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obstructive sleep apnoea (OSA) is a sleep and breathing disorder characterised by repetitive closure or narrowing of the airway during sleep. The upper airway muscles play an important role in keeping the upper airway open. In addition to the non-respiratory functional tasks of speech and swallowing, they serve an important role in tongue protrusion, airway stiffening/support and dilation during breathing. Conversely, poor upper airway muscle function plays a key role in the pathophysiology of OSA. Indeed, more than 30% of patients with OSA have minimal activation of the upper airway muscles during airway narrowing and closure during sleep. Although recent studies highlight the potential of oropharyngeal muscle training as a non-invasive approach to therapy a major unresolved question is: how does oropharyngeal exercise training improve upper airway muscle function to reduce OSA severity? To answer this question, the current study will evaluate changes in OSA severity and upper airway physiology following an upper airway muscle training protocol.

Interventions

12 weeks of targeted upper airway muscle training to improve obstructive sleep apnoea. The training will commence the day after the participants first PSG study. Exercises will target the soft palate, tongue and sub-mental muscles. Training will involve the use of an Expiratory Muscle Strength Trainer (EMST) and an IOPI medical device. Participants will instructed on the exercises on day one, week 1, during a face-face consultation. Participants will have bi-weekly sessions with a speech path

12 weeks of targeted upper airway muscle training to improve obstructive sleep apnoea. The training will commence the day after the participants first PSG study. Exercises will target the soft palate, tongue and sub-mental muscles. Training will involve the use of an Expiratory Muscle Strength Trainer (EMST) and an IOPI medical device. Participants will instructed on the exercises on day one, week 1, during a face-face consultation. Participants will have bi-weekly sessions with a speech pathologist by video consultation. Training will be completed daily (~30 mins) at home for 12 weeks. Participants will be asked to complete a daily training diary to monitor adherence to the training protocol. Training will involve (1) prolonged holds and (2) pulses on an air-filled tongue bulb. The number of repetitions will be tailored to participants' baseline performance. For example, during baseline testing, participants maximum repetitions and durations will be determined. Participants will perform the hold at 50% of max effort (as they get "stronger" this value will increase, but it will always remain at 50% max effort). The repetitions will increase by 5% bi-weekly. This will be done during bi-weekly consultations with the speech-pathologist. Similarly, the EMST starting resistance will be tailored to participants' baseline peak expiratory flow. During baseline testing, participants max peak expiratory effort will be determined. Each week, the EMST will be increased by a quarter turn (as per EMST protocol). Participants will complete 5 sets of EMST comprising 5 repetitions per set. This will be completed 5 times per week (as per EMST protocol).

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Male or female Otherwise healthy with a confirmed diagnosis of OSA. AHI greater than 5 events/h on pre-training PSG night. Currently not on treatment, or have previously failed treatment for OSA

Exclusion criteria

Clinically significant craniofacial malformation. Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. Clinically significant neurological disorder, including epilepsy/convulsions. Clinically significant cognitive dysfunction Participants who have had upper airway surgery < 1 year prior to participation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026