|- candidate number||23455|
|- NTR Number||NTR5786|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2015|
|- Secondary IDs||54752 // 19870826 ABR nummer // protocol nummer|
|- Public Title||DiagnOSAS as a screeningstool for obstructive sleep apnea syndrome in the primary care setting|
|- Scientific Title||DiagnOSAS as a screeningstool for obstructive sleep apnea syndrome in the primary care setting|
|- ACRONYM||DiagnOSAS, diagnosis of sleep apnea syndrome|
By offering a screeningstool for OSAS in the first line (general practitioners), it is expected that diagnosing OSAS becomes easier, faster, cheaper, more efficient, patientfriendly, and is also accessible to a wider audience.
|- Healt Condition(s) or Problem(s) studied||Sleep apnea, Obstructive sleep apnea syndrome, Fatigue, Primary care|
|- Inclusion criteria||
Patients> 18 years with suspected obstuctief sleep apnea syndrome (OSAS) who are referred by their GP to a sleep center for further diagnostic testing (polygraphy).
|- Exclusion criteria||- Bodily deformaties making the wearing of a finger pulse oximeter impossible|
- incompentent patients
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mrt-2016|
|- planned closingdate||23-dec-2017|
|- Target number of participants||150|
|- Interventions||Patients will ﬁll in a short online questionnaire (25 questions). Furthermore, the overnight oxygen levels in the blood will be recorded non-invasive by continuous pulse-oximetry at home. Finally they ﬁll in a feedback form of 5 questions.
|- Primary outcome||To assess the diagnostic value of overnight pulse-oximetry as a screeningstool for OSAS in the first line in terms of positive predictive value and sensitivity. Polygraphy, evaluated using both quantitative and qualitative methods, is hereby considered the gold standard.
|- Secondary outcome||i) Negative predictive value and specificity of pulse-oximetry as diagnostic marker for OSAS in the first line.|
ii) Negative predicitive value, positive predictive value, sensitivity, and specificity of the Philips questionnaire as
diagnostic marker for OSAS.
iii) Usability of DiagnOSAS for patients.
iv) Realized cost savings when using DiagnOSAS with respect to the gold standard.
|- Timepoints||Having general practitioners use DiagnOSAS for research purposes, conducting the research, gathering data, analyzing data will cost an estimated 1 year (end date 01-03-2017).|
|- Trial web site|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. K. Veldhuis|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K. Veldhuis|
|- Sponsor/Initiator ||MST Enschede|
(Source(s) of Monetary or Material Support)
|MIRA institute, University of Twente, Menzis|
|- Brief summary||In obstructive sleep apnoea syndrome (OSAS), repetitive pauses in breathing during sleep occur, ranging from ﬁve to more than thirty times per hour. OSAS is associated with complaints of fatigue and daytime sleepiness, which often results in dysfunction in social and professional live. |
Furthermore, the risk of (traﬃc) accidents, cardiovascular diseases, diabetes and dementia increases with severe OSAS (Apnoea-hypopnoea index (AHI) > 30). OSAS is diagnosed in hospitals or specialized sleep centres. By screening patients in the general practitioner clinic, patients can be referred more selective to the hospitals / sleep centres. It is expected that the diagnostics of OSAS will become easier, cheaper, more eﬃcient and above all, better accessible due to shorter waiting lists.
|- Main changes (audit trail)|
|- RECORD||5-dec-2015 - 23-feb-2018|