Zeus-OSA
Research type
Research Study
Full title
Transcutaneous electrical nerve stimulation of the hypoglossal nerve in Obstructive Sleep Apnoea compared with placebo device
IRAS ID
311802
Contact name
Chris Jones
Contact email
Sponsor organisation
Morgan Innovation & Technology Ltd.
ISRCTN Number
ISRCTN84984622
Clinicaltrials.gov Identifier
EDGE, 151827
Duration of Study in the UK
0 years, 6 months, 26 days
Research summary
Obstructive Sleep Apnoea (OSA) is the frequent relaxation of the throat muscles to the point where airflow is narrowed or blocked, causing oxygen deprivation. OSA severity is measured by the Apnoea/Hypopnoea Index (AHI). Untreated OSA is strongly linked to higher rates of cardiovascular, metabolic, and psychiatric disease, as well as poorer quality of life. In the UK, people with mild OSA are offered lifestyle advice, while moderate and severe OSA is treated with the gold-standard therapy, CPAP (Continuous Positive Airway Pressure): wearing a facemask attached by a hose to an air pump device during sleep. Adherence is notoriously variable with 25-38% of patients failing to use it effectively.
A surgically implantable device which electrically stimulates the hypoglossal nerves in the jaw to flatten the tongue and open the airway has been accepted as an alternative treatment in several countries, but this involves expensive invasive neurosurgery and is not fully effective in some patient groups. The non-invasive ZeusOSA device uses the same theory but sticks to the skin under the jaw.
This double-blind randomised crossover study will investigate whether the ZeusOSA device is effective in improving AHI in OSA patients, using paired active and sham devices.
Patients recently diagnosed with OSA at Dorset County Hospital who are following lifestyle advice or waiting to start CPAP therapy will be recruited. Participation will have no impact on their treatment pathway. Patients will have a baseline home sleep study, then undergo two periods of week-long acclimatisation to the device, ending with another home sleep study, for a total of fifteen nights. Neither patients nor participants will know which device is active and which is sham. Further sleep-quality information will be gathered over the whole study via pulse oximeter and qualitative information on perceived sleep quality and daytime alertness will be gathered by daily questionnaire.
REC name
HSC REC B
REC reference
22/NI/0150
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion