Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy (DOT-PSG)

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.

Study Overview

• Status: Recruiting
• Conditions: Apnea; Obstructive Sleep Apnea; Sleep Apnea
• Intervention / Treatment: Other: Daytime titration polysomnography

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 Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Dorine Van Loo, Msc; Phone Number: +3238215780; Email: dorine.vanloo@uza.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Principal Investigator: Olivier Vanderveken, MD, PhD
      • Contact: Dorine Van Loo, Msc; Phone Number: +3238215780; Email: dorine.vanloo@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not able to understand the language of the questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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	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	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	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.	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	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	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	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	From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Olivier Vanderveken, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hypoglossal nerve stimulation; titration polysomnography
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: B3002024000122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No