Status:
COMPLETED
Validation of a Simplified MATRx Plus
Lead Sponsor:
Zephyr Sleep Technologies
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-80 years
Brief Summary
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous p...
Detailed Description
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous p...
Eligibility Criteria
Inclusion
- Aged between 21 and 80 years
- Obstructive sleep apnea (ODI \> 10 h-1)
- Body mass index \< 45 kg/m2
- Neck circumference \< 50 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by a mean value of oxyhemoglobin saturation (SaO2) \> 87%
- Mandibular range of motion \> 5 mm
- Adequate dentition (10 upper and 10 lower teeth)
- Ability to understand and provide informed consent
- Ability and willingness to meet the required schedule
Exclusion
- Inability to breathe comfortably through the nose
- Central Sleep Apnea (\> 50% of apneas are central)
- Anticipated change in medical therapy that could alter the severity of OSA during the protocol
- Anticipated change in body weight (5% or more) during the protocol
- Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
- Severe respiratory disorder(s) other than sleep disordered breathing
- Loose teeth, faulty restorations, or advanced periodontal disease
- Participation in other studies that could interfere with study protocol
- Pregnant or nursing
- Heart failure
- Cerebral vascular incident within the last 12 months
- Use of pacemaker or other life supporting device
- Regular use of CPAP or oral appliance therapy within 5 days of the PSG or HSAT (individuals on therapy wishing to participate may opt to cease therapy for the 5 nights prior to each test)
Key Trial Info
Start Date :
February 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03812692
Start Date
February 6 2019
End Date
March 1 2021
Last Update
March 4 2021
Active Locations (1)
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1
Zephyr Sleep Technologies
Calgary, Alberta, Canada, T2H-2C3