Sleep ApneaNCT03635918
Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test
A study testing NightOwl HSAT in people with Sleep Apnea, run by Ectosense NV at 1 site in Belgium.
Trial summary
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- NightOwl HSAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2018to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for a sleep study
Who cannot join
- Mentally disabled people
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Inge Thijs, PhD, 089 32 15 55 ext. +32, Inge.Thijs@zol.be
About this study
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.
Read the detailed description
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.
- Conditions
- Sleep Apnea
- Being tested
- NightOwl HSAT
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightOwl HSATDevice
Patient wears the NightOwl sensor device
| Study group | Role | What they receive |
|---|---|---|
| NightOwl HSAT | Other | 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. Receives: Device: NightOwl HSAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
Measured: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Secondary outcomes (1)
Sleep-wake discrimination
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
Measured: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Aug 2018
- Primary completion15 Sep 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ectosense NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
- Investigators
- Frederik Massie, ir., Study director, Ectosense NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635918
- Sponsor's protocol ID
- 17/034-11/06/2018
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test
- ClinicalTrials.gov ID
- NCT03635918
- Acronym / sponsor ID
- 17/034-11/06/2018
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ectosense NVIndustry (pharma, biotech, devices)
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NightOwl HSAT | Other | Device: NightOwl HSATPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for a sleep study
Key exclusion criteria (1 listed)
- Mentally disabled people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightOwl HSATPatient wears the NightOwl sensor device | Device | NightOwl HSAT |
Primary outcome
Apnea-Hypopnea Index (AHI)
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
Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
1 secondary outcome
Sleep-wake discrimination
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Massie, ir. study director
Ectosense NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NightOwl HSAT in people with Sleep Apnea, run by Ectosense NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Massie, ir. (474942710 ext. +32, frederik.massie@ectosense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.