Primary objective of the study is to create one or multiple light ring(s) in the upper airway of OSA patients by means of Single Ring Optical Catheter(s), visualize and record these light rings with a DISE endoscope, capture the change of light ring…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visuality of light ring projection on airway wall, configuration change during
collapse and separation between the light rings.
Secondary outcome
n.a.
Background summary
Drug Induced Sleep Endoscopy (DISE) represents the most widespread diagnostic
tool for evaluation of the anatomical root cause of Obstructive Sleep Apnea
(OSA) in patients. Disadvantages of DISE are that a patient needs to be
sedated, OSA events are visualized during drug induced sleep instead of natural
sleep, that events can only be monitored at one location at a time, and the
examination is for a short period of time only. As a first step in developing
an improved diagnostic device, a newly developed optical catheter will be used
during DISE.
Study objective
Primary objective of the study is to create one or multiple light ring(s) in
the upper airway of OSA patients by means of Single Ring Optical Catheter(s),
visualize and record these light rings with a DISE endoscope, capture the
change of light ring configuration during collapse of the airway and identify
longitude and separation of collapse-critical sites in the human upper airway.
Study design
observational study
Study burden and risks
The risks for the subjects participating in this study are negligible. Burden
to the healthy volunteers consists of an endoscopic examination of the upper
airway and the insertion via a nostril of optical catheters for a maximum of
thirty minutes. Burden to the OSA patients consists of a slighly longer
sedation time following DISE. Both groups can possibly experience some
temporary irritation of the upper airway wall after the procedure.
High Tech Campus 34
Eindhoven 5656AE
NL
High Tech Campus 34
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects:
+ 18 years and older;OSA patients:
+ 18 years and older
+ diagnosis with moderate or severe OSA (AHI>15)
+ scheduled to undergo DISE
Exclusion criteria
Healthy subjects and OSA patients:
- morphological nasal airway abnormalities prohibiting entry of both nostrils by the endoscope or catheter
- nasal congestion prohibiting entry of both nostrils by the endoscope or catheter
- patients with suspected sensitivity to light, e.g. patients who had photodynamic therapy
-inability to provide informed consent
- pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55077.029.15 |