None listed
Conditions
Brief summary
This is a phase 1 proof of concept trial measuring the effect of a novel intranasal stent and tolerability of an expiratory positive pressure device on subjects with moderate obstructive sleep apnoea. Hypothesis: The combination fo dilation of the nasal cavity with an intranasal stent combined with a valve that increases pressure to the upper airway on expiration will favorably effect moderate sleep apnoea and snoring.
Interventions
A phase 1, proof of concept pilot series will evaluate the use of Rhinomed's prototype of an intranasal stent and positive expiratory pressure device (RHI-003 NBV001) for moderate obstructive sleep apnoea. This stenting device contains a one way valve that facilitates inspiration unimpeded and delivers an expiratory resistance that creates expiratory positive pressure to the pharynx. 20 subjects are fitted and trained to self insert the device by the researchers. Polysomnography using the device
A phase 1, proof of concept pilot series will evaluate the use of Rhinomed's prototype of an intranasal stent and positive expiratory pressure device (RHI-003 NBV001) for moderate obstructive sleep apnoea. This stenting device contains a one way valve that facilitates inspiration unimpeded and delivers an expiratory resistance that creates expiratory positive pressure to the pharynx. 20 subjects are fitted and trained to self insert the device by the researchers. Polysomnography using the device on night 1 will compare sleep apneoa severity to baseline. Two weeks of nightly usage in their own home will be monitored with self reported compliance log and repeat partner assisted snoring analogue scale questionnaire. Subjects will be assigned a device for night 1 to 3 with a non-therapeutic expiratory effect with 2.5mm valve diameter, nights 3 to 6 with 2mm valve diameter and then nights 7-14 with therapeutic expiratory effect with a 1.5mm valve diameter. This will assist with acclimation.
Sponsors
Monash Lung and Sleep
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Moderate obstructive sleep apnoea (apnoea hypopnoea index >15 events per hour and <30 events per hour). - Witness in the domestic environment to report on snoring severity.
Exclusion criteria
- Unable to fit intranasal stent device comfortably - Unable to provide informed consent - Major cardiorespiratory comorbidity - Current treatment for obstructive sleep apnoea
Outcome results
None listed