Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

Obstructive Sleep Apnea Clinical Trial

— B-HNS  

Official title:

Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332404
• Other study ID #: B3002024000047
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: April 2034

Study information

• Verified date: March 2024
• Source: University Hospital, Antwerp
• Contact: Dorine Van Loo, MSc
• Phone: +3238215780
• Email: dorine.vanloo[@]uza.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital.

Description:

Patients that are implanted with the Inspire system at the Antwerp University Hospital will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. 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 routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: April 2034
• Est. primary completion date: April 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS

implantation if he/she meets the following criteria:

• At least 18 years old at the time of implantation
• The patient suffers from moderate to severe OSA (15 events/h = AHI = 65 events/h)
• The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy
• Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)

Exclusion Criteria:

• Body mass index (BMI) >32 kg/m².
• Combined mixed and central AHI is more than 25% of the total AHI
• Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS
• Patients with severely impaired neurological control over the upper airway
• Pregnancy
• Surgery performed on the soft palate in the past three months before implantation.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
Hypoglossal nerve stimulation therapy

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta apnea-hypopnea index (AHI) as measured by a 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.	From baseline to 6, 12 and 60 months post-implantation
Secondary	% 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	At 6, 12 and 60 months post-implantation
Secondary	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	At 6, 12 and 60 months post-implantation
Secondary	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.	From baseline to 6, 12 and 60 months post-implantation
Secondary	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.	From baseline to 6, 12 and 60 months post-implantation
Secondary	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.	From baseline to 6, 12 and 60 months post-implantation
Secondary	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	From baseline to 6, 12 and 60 months post-implantation