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 2018-08-17.
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 has the largest planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2018, is one of 16 with no phase, and was the 17th 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. 2 started in 2018.
This study's planned enrollment of 500 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.
This tab as a report to print or save as PDF → With an account.
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:
This tab as a report to print or save as PDF → With an account.
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.
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 benchmark HSAT 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 benchmark HSAT 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 benchmark PSG and HSAT monitors.
Time frame: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Sleep-wake discrimination
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
Time frame: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2018 (actual). Primary completion is estimated for Sep 2019, 13 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 13 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 Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.