Obstructive Sleep Apnea
Conditions
Keywords
Hypoglossal nerve stimulation, Drug-induced sleep endoscopy
Brief summary
The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data. Furthermore, outcomes will be compared between responders and non-responders.
Detailed description
Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE. To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.
Interventions
DEVICEHypoglossal nerve stimulation implant
The hypoglossal nerve stimulation (HNS) implantation and therapy will be performed according to the standard clinical practice without additional procedures. Information about the surgical procedure will be collected. HNS implant information and settings will be collected throughout the study until the last study measurement (one year follow-up PSG and DISE) for that patient. No additional measures or interventions as part of the research project will be performed during implantation or treatment with HNS.
DIAGNOSTIC_TESTPolysomnography
A PSG at one-year follow-up is part of the standard follow-up pathway in patients receiving HNS therapy. In this study, PSG data will be collected from both baseline and one-year follow-up PSGs to assess treatment effect. Additionally, PSG data will be used for non-invasive prediction of the site and pattern of collapse using a novel, validated tool developed at our research group.
PROCEDUREDrug-induced sleep endoscopy (DISE)
Drug-induced sleep endoscopy (DISE) is the clinical standard diagnostic test to assess site, pattern and degree of upper-airway collapse in OSA. Baseline DISE is part of the standard clinical pathway for HNS eligibility. In this study, DISE data will be collected from routine baseline DISE without any additional procedures for the patient. They will undergo an additional DISE at one-year follow-up to assess the effect of HNS-therapy on site, pattern and degree of collapse. Both DISEs will be performed according to routine clinical practice in the operating theatre. Sleep will be induced using 1.5 mg bolus injection midazolam and target-controlled propofol infusion (2.0 - 3.0 μg). A flexible fiberoptic nasopharyngoscope will be transnasally inserted. Site, pattern and degree of collapse will be assessed using a standardized scoring system. Other maneuvers, including chin-lift, the use of a simulation bite or lateral position of the head will be performed according to clinical practice.
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Before-and-after study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Eligible for HNS-therapy: * AHI between 15 and 65 events/hour * BMI under 32 kg/m2 * Absence of complete concentric collapse of palate (CCC) on DISE * Intolerance or failure of continuous positive airway pressure (CPAP)-treatment * Intolerance or failure of mandibular advancement device (MAD)-treatment * Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years) * Scheduled for HNS-implantation at the Antwerp University Hospital * Capable of giving informed consent * Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital
Exclusion criteria
* Patients will not receive HNS-therapy at the Antwerp University Hospital * Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Δ%area-of-collapse at the level of the lateral walls | Between baseline and one year follow-up | The percentage of the area of collapse at the level of the lateral walls - measured using DISE - will be calculated using ImageJ software. The percentage difference of collapse between baseline and one-year follow-up will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Δ%area-of-collapse at the level of the palate, tongue base and epiglottis | Between baseline and one year follow-up | The percentage of the area of collapse at the level of the palate, tongue base and epiglottis - measured using DISE - will be calculated using ImageJ software. The percentage difference of collapse between baseline and one-year follow-up will be calculated. |
| Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders | Between baseline and one year follow-up | The Δ%area-of-collapse will be specifically identified in the group of responders and the group of non-responders, to compare these two groups. |
| DISE-score during baseline DISE and during one-year follow-up DISE. | At baseline and at one-year follow-up | DISE-scores (pattern and degree of collapse at each site of upper airway collapse) will be scored to assess the effect of HNS on this outcome. |
| Non-invasive site and pattern of collapse | At baseline and at one-year follow-up | Non-invasive site and pattern of collapse assessed using the novel developed and validated tool at baseline and 1-year follow-up. |
Countries
Belgium
Contacts
Primary ContactEldar Tukanov, MD
Outcome results
None listed