An interventional study of NightOwl HSAT in Sleep Apnea, sponsored by Ectosense NV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Ectosense NV (part of ResMed) · Not applicable, Interventional, and Diagnostic
Among 33 studies in Sleep Apnea Syndromes with a site in Belgium — 7 open to participants now, 9 under way, none of them phase 3. Sleep Apnea Syndromes · Belgium.
Among the 33 studies in Sleep Apnea Syndromes with a site in Belgium, this one is the 2nd largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2017, is one of 16 with no phase, and was the 15th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
Browse Sleep Apnea Syndromes studies →7 of the 33 studies in Sleep Apnea Syndromes with a site in Belgium are open now. Recruiting first, the newest first:
Université Catholique de Louvain · Sites in Belgium
Inspire Medical Systems, Inc. · Sites in Belgium, Austria, France and 4 more countries
University Hospital, Antwerp · Sites in Belgium
University Hospital, Antwerp · Sites in Belgium
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 450 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Median enrollment 21 across the 17 interventional studies, 200 across the 15 observational. Of the 18 that completed or were terminated, 2 (11%) have results posted.
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10 of 33 have an industry lead sponsor. The 10 most frequent:
Ectosense NV is the lead sponsor of 6 studies on the registry; none are open to participants now.
Ectosense NV has 4 studies filed under Sleep Apnea Syndromes — fewer than ten, so there is no comparison to draw.
1 of the studies in Sleep Apnea Syndromes with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06915077University Hospital, AntwerpPersonalised Treatment for OSA | 2027-01 |
Among the 33 studies in Sleep Apnea Syndromes with a site in Belgium, from their registry updates:
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Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor.
Device: NightOwl HSAT
Patient wears the NightOwl sensor device
Apnea-Hypopnea Index (AHI)
Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
Time frame: At the time of the diagnostic night
Sleep-wake discrimination
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
Time frame: At time of the diagnostic night
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for Sep 2019, 26 months after the start.
Of 68 industry-sponsored interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's planned 26 months is above that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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