We hypothesize that sleep apnea screening, using a combination of an online questionnaire and high resolution overnight oximetry, can safely be applied to exclude sleep apnea with high sensitivity (≥97%) and acceptable specificity (≥60%) in patients…
ID
Source
Brief title
Condition
- Respiratory tract signs and symptoms
Synonym
Health condition
Sleep apnea is a sleep-related breathing disorder in which repetitive pauses in breathing, periods of shallow breathing, or collapse of the upper airway during sleep results in poor ventilation and sleep disruption.
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
The primary study endpoints are the sensitivity and negative predictive value of the screening algorithm to detect sleep apnea.
Secondary outcome
Secondary endpoints are the specificity and positive predictive value of the screening algorithm as well as quantification of the occurrence of alternative sleep disorders in patients in who sleep apnea was initially suspected.
Background summary
This study is a prospective multicenter trial aimed at external validation of an optimized screening algorithm (consisting of an online questionnaire combined with high-resolution overnight oximetry) for the exclusion of sleep apnea in patients presenting with symptoms possibly due to sleep apnea. Polysomnography will be applied as a gold standard to confirm or exclude the final diagnosis of sleep apnea. The primary study endpoints are the sensitivity and negative predictive value of the screening algorithm to detect sleep apnea. Secondary endpoints are the specificity and positive predictive value of the screening algorithm as well as quantification of the occurrence of alternative sleep disorders in patients in who sleep apnea was initially suspected.
Study objective
We hypothesize that sleep apnea screening, using a combination of an online questionnaire and high resolution overnight oximetry, can safely be applied to exclude sleep apnea with high sensitivity (≥97%) and acceptable specificity (≥60%) in patients in who sleep apnea was initially suspected based on symptoms.
Study design
Patients will fill out an online questionnaire prior to the polysomnography. In addition, patients will wear an OSAsenseS18 device (oximeter) on the contralateral wrist on the night of the polysomnography.
Age
Inclusion criteria
Patients aged 18 years or older who present with signs or symptoms possibly due to sleep apnea and who are planned to undergo polysomnography for final diagnosis.
Exclusion criteria
Patients who are legally incapable or in who only a polygraphy (i.e. no polysomnography) is performed are excluded from the study.
Design
Recruitment
Medical products/devices used
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7797 |
| Other | METC MST : METC19133 |