Adverse Effects, Obstructive Sleep Apnea
Conditions
Keywords
OSA
Brief summary
Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve Provent in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.
Interventions
DEVICEnasal peep valve Provent
application of nasal peep valve vs dental device and cpap
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI \> 10/hr) * Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA. * Able to sign informed consent and use the PEEP nasal valve. * Age between 18-65 years old. * Willing to attend follow up.
Exclusion criteria
* Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve. * Unable to sign consent or use PEEP nasal valve. * Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority. * Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index (AHI) | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| side effects as a measure of tolerability | 1 month |
Countries
Hong Kong
Outcome results
None listed