Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

NCT06559956 | Recruiting

• 1 other identifier: B3002024000122
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Apnea

Keywords

hypoglossal nerve stimulation; titration polysomnography

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  At the postoperative titration follow-up (approximately 3 months after activation of the therapy)

• Full-night AHI as measured during a titration polysomnography

  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

  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

  At the postoperative titration follow-up (approximately 3 months after activation of the therapy)

Study Arms (2)

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.

Other: Daytime titration polysomnography

Interventions

Daytime titration polysomnography OTHER

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.

Daytime titration polysomnography cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)

You may qualify if:

• 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

You may not qualify if:

• Not able to understand the language of the questionnaires

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Vanderveken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorine Van Loo, MSc

CONTACT

+3238215780; dorine.vanloo@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 19, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)