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
Summary of Research
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.
Summary of Results
The study title is: Transcutaneous electrical hypoglossal nerve stimulation in OSA patients – a double-blind randomised crossover trial against placebo device.
This means that we are trying to see if a recently developed device, worn under the chin when sleeping, which delivers small electrical impulses can be used to successfully treat patients who have a sleep-related breathing order (Obstructive Sleep Apnoea – OSA).
The current main treatment for OSA involves wearing a mask connected to a machine, which pumps air into the individuals’ nose and mouth. This treatment, called CPAP (Continuous Positive Airways Pressure), is very successful at treating OSA but many people find it too uncomfortable to tolerate and so this study is investigating a potential alternative treatment for this condition.
The trial requires participants to wear two versions of the Zeus device – an Active device (which delivers the small electrical impulses all night) and a placebo device. The placebo device initially delivers these impulses but then turns off when the participant falls asleep and so does not deliver any therapy overnight.
The trial was conducted by healthcare scientists at Dorset County Hospital (Dorchester, Dorset) and the study was funding by the National Institute for health Research Innovation Connect Research Grant, which was paid directly to Morgan IAT Ltd, the developer and manufacturer of the device.
The trial was conducted in the participants homes following hospital visits, and involved them wearing not only the therapeutic device, but also several pieces of sleep equipment to monitor their breathing, oxygen levels and pulse rate whilst asleep, every night for a period of two weeks. This can make sleeping with all this equipment challenging for the participants. They were also asked to complete daily questionnaires on how well they slept, how comfortable they found the device, did they feel that their sleep quality improved, etc.
In total 62 patients were recruited to this trial which resulting in 48 full datasets, with 12 participants withdrawing or being excluded from the primary analysis. When the data was analysed as a whole group of 48, the primary outcome demonstrated no significant difference in the number of apnoeas/hypopnoeas (measures of breathing disturbances) occurring per hour between baseline (no device being worn) and Active ZeusOSA use (the therapeutic device being trialled).
Further analysis of the study data identified a sub-group of participants (referred to as “responders”) who did have a significant reduction in the number of breathing disruptions per hour and disturbance of oxygen levels per hour whilst using the Active ZeusOSA device. These responders also reported subjective improvements in perceived sleep quality, perceived daytime alertness and perceived daytime functionality.
Those using the Active ZeusOSA device also had increases in pulse rate compared to baseline which this study could not explain.
Attempts were made to see why the responder participants may have had a positive response to wearing the Active device. The only difference that could identified responders was that they had a significantly higher autonomic arousal index (AAI) at baseline. This means that they had a higher number of pulse rate disturbances, per hour, overnight which can suggest a higher amount sleep fragmentation (interruptions) and therefore worse sleep quality.
Further studies are needed to see if other characteristics can be identified to recognise those who would benefit from wearing a Zeus Active device.
The participants experience of wearing these devices was positive, with only 4 participants experiencing minor skin irritation from the adhesive used to fix the device in place overnight.REC name
HSC REC B
REC reference
22/NI/0150
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion