Obstructive sleep apnoea Nervous System Diseases Sleep apnoea
Conditions
Interventions
The proposed study aims to investigate the effectiveness of a modified Zeus device called ZeusOSA in improving sleep-disordered breathing and related symptoms in OSA patients via a randomised double-b
Sponsors
Morgan Innovation and Technology (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: OSA patients awaiting CPAP therapy or treating symptoms with lifestyle changes
Exclusion criteria
Exclusion criteria: Participants meeting any of the following will be excluded: 1. Participants with complex sleep disorders such as central sleep apnoea, REM-related parasomnias, restless leg syndrome, periodic limb movement disorder, chronic insomnia or paradoxical insomnia, sleep disorders caused by medications or drugs, or other sleep disorders that the Chief Investigator or his deputies consider may contaminate the focus of the study. 2. Participants with significant co-morbidities such as heart failure, respiratory failure, uncontrolled diabetes, polyuria, neuromuscular disorders, or other medical conditions that the Chief Investigator or his deputies consider may contaminate the focus of the study. In addition, the following are contraindications to using the ZeusOSA device as stated by the manufacturer, Morgan IAT Ltd., therefore participants meeting any of the following will be excluded: 1. Participants fitted with a pacemaker, defibrillator, or any other implantable medical devices 2. Participants with metal implants (excluding fillings) in the head and neck region 3. Participants diagnosed with cancer in the head and neck region 4. Participants who have had head or neck surgery in the last 6 months 5. Participants with swollen, infected, inflamed areas or broken skin under the jaw 6. Participants who have a recently diagnosed (last two months) deep vein thrombosis (DVT) 7. Participants experiencing unstable cardiovascular status including uncontrolled hypertension and arrhythmias 8. Participants experiencing recurrent seizures, epilepsy, or migraines 9. Participants experiencing cognitive impairment, including cognitive impairment caused by medication, drug, or alcohol use, or those who are unable to give informed consent 10. Participants with thick facial hair under the jaw who do not wish to shave, or patients who use moisturising creams on the skin under the jaw who do not wish to pause this routine 11. Participants using any other any other medical devices during sleep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnoea-Hypopnoea Index will be measured by multi-channel sleep study on Days 0, 7 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oxygen Desaturation Index will be measured by multi-channel sleep study on Days 0, 7 and 14, and also by pulse oximeter on Days 0-14 2. Snoring will be measured by multi-channel sleep study on Days 0, 7 and 14 3. Perceived sleep quality will be measured by weekly questionnaire on Days 0, 8 and 15; and also by daily questionnaire on days 1-15 4. Perceived daytime sleepiness will be measured by weekly questionnaire on Days 0, 8 and 15; and also by daily questionnaire on days 1-15 5. Perceived daytime alertness will be measured by weekly questionnaire on Days 0, 8 and 15; and also by daily questionnaire on days 1-15 6. Perceived daytime functionality will be measured by a weekly questionnaire on Days 0, 8 and 15 7. Short-term trends in the efficacy of the Zeus device will be measured by analysis of ODI recorded by pulse oximeter on Days 0-14 and sleep quality, daytime sleepiness, and daytime alertness recorded by daily questionnaire on Days 1-15 8. Tolerance of the Zeus device will be measured by weekly questionnaire on Days 8 and 15 | — |
Countries
England, United Kingdom
Outcome results
None listed