Obstructive Sleep ApneaDOT-PSGNCT06559956
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- What is being tested?
- Daytime titration polysomnography
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Aug 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
Who may be able to join
- Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
- Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital
- Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital
- Able to give informed consent
Who cannot join
- Not able to understand the language of the questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Dorine Van Loo, Msc, +3238215780, dorine.vanloo@uza.be
Olivier Vanderveken, MD, PhD
About this study
Official title: Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options.
Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.
The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.
Read the detailed description
This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.
Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring. Data will be collected from different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- Being tested
- Daytime titration polysomnography
- Keywords
- hypoglossal nerve stimulation, titration polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daytime titration polysomnographyOther
A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.
| Study group | Role | What they receive |
|---|---|---|
| Overnight titration polysomnography cohort | A cohort of OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway | |
| Daytime titration polysomnography cohort | OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG. Receives: Other: Daytime titration polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography
The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Secondary outcomes (11)
Percent of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h
AHI is determined during a polysomnography
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Treatment AHI as measured during a titration polysomnography
The treatment AHI, also called the titrated AHI, is the AHI measurement from the portion of sleep when therapy is under therapeutic setting found for home use
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Full-night AHI as measured during a titration polysomnography
Full-night AHI is the AHI determined from the complete titration polysomnography.
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Percent of time spent in each sleep stage as measured during a titration polysomnography
Sleep architecture is the structure of the sleeping pattern, including rapid-eye movement sleep (REM) and nonREM sleep, and is measured during a polysomnography
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Percent of time spent in different body positions during a titration polysomnography
The body position is recorded during a polysomnography
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Delta oxygen desaturation index (ODI) as measured by a polysomnography
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during a polysomnography
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
The ESS questionnaire assesses the probability of falling asleep in various settings and situations in daily life. This questionnaire consists of eight questions which can be scored on a four-point Likert-type scale. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. The summation of the eight items can range from 0 to 24.
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire
The FOSQ-30 is a disease-specific quality of life questionnaire that determines functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The total score equals the mean scores for each subscale (5 in total) multiplied by the number of subscales answered (total score range 5-20, with higher scores indicating better functional status
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire
Snoring intensity is evaluated using a 10 cm visual analogue scale (VAS) from 0 to 10: 0 represents no snoring, 1-3 represents minimally annoying, 4-6 represents moderately annoying, 7-9 represents annoying, and 10 represents extremely annoying
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Therapy adherence defined by the amount of hours therapy usage per night
Average hours of therapy use per night can be retrieved from data stored in the device
Measured: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography
SASHB is calculated as the oxygen desaturation "area under the curve" in association with individual apneas and hypopneas
Measured: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start27 Aug 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Vanderveken, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559956
- Sponsor's protocol ID
- B3002024000122
- Acronym
- DOT-PSG
- Status last verified
- Apr 2025
- First submitted
- 29 Jul 2024
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06559956
- Acronym / sponsor ID
- DOT-PSG / B3002024000122
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Apnea
- Keywords
- hypoglossal nerve stimulation, titration polysomnography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 2024 (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.
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options.
Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.
The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.
Detailed description
This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.
Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring. Data will be collected from different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overnight titration polysomnography cohort | – | –A cohort of OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway |
| Daytime titration polysomnography cohort | – | Other: Daytime titration polysomnographyOSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
Key inclusion criteria (4 listed)
- Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
- Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital
- Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital
- Able to give informed consent
Key exclusion criteria (1 listed)
- Not able to understand the language of the questionnaires
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 |
|---|---|---|
| Daytime titration polysomnographyA titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab. | Other | Daytime titration polysomnography cohort |
Primary outcome
Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep
11 secondary outcomes
Percent of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Treatment AHI as measured during a titration polysomnography
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Full-night AHI as measured during a titration polysomnography
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Percent of time spent in each sleep stage as measured during a titration polysomnography
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Percent of time spent in different body positions during a titration polysomnography
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Delta oxygen desaturation index (ODI) as measured by a polysomnography
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Therapy adherence defined by the amount of hours therapy usage per night
Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Olivier Vanderveken, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by University Hospital, Antwerp 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 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorine Van Loo, MSc (+3238215780, dorine.vanloo@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography (time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)). 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 10 Sep 2025.