An interventional study of Upper Airway Stimulation in Obstructive Sleep Apnea, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. This study is a prospective, multi-center, double-blinded, randomized crossover study conducted under a common protocol. The study visits include baseline with an in-laboratory polysomnography (PSG) after six months of therapy usage, followed by visits and in-lab PSGs at 1 and 2-weeks where the Therapy stimulation will be changed at each, according to randomization. The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.
The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.
The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration [7].
The Inspire system is comprised of the following components:
External programmers used with the system are:
The Inspire system received CE Mark in 2010 (CE Certificate No. 562872) providing the regulatory authority to provide the device in a commercial setting. Furthermore, this study will be conducted within the CE marked intended use of the Inspire system and will not involve any additional stressful or invasive tests.
The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 100 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Technical University of Munich is the lead sponsor of 319 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Otherwise healthy subjects that are at least 18 years old and:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this clinical investigation:
Therapeutic Stimulation: optimal therapy setting for home use
Device: Upper Airway Stimulation
Sham Stimulation (Control Group): stimulation voltage programmed at 0.1 volts
Device: Upper Airway Stimulation
hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway
Also known as: Inspire
Change in AHI from Baseline to Visit 1 and Visit 2
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in ESS from Baseline to Visit 1 and Visit 2
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in FOSQ from Baseline to Visit 1 and Visit 2
The Functional Outcomes of Sleep Questionnaire (FOSQ) is a validated instrument to assess the effect of a subject's daytime sleepiness on activities of ordinary living. The FOSQ endpoint will be determined by the FOSQ score at Visit 1 and Visit 2 as compared to baseline.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Snoring Intensity from Baseline to Visit 1 and Visit 2
Snoring Intensity will be measured by using a visual analoge scale from 0 (no snoring) to 10 (heavy snoring). The snoring intensity endpoint will be determined by the visual analogue scale at Visit 1 and Visit 2 as compared to baseline.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Therapy Adherence
Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic. This value can be used to quantify device use and adherence over the investigated time period.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in ODI from Baseline to Visit 1 and Visit 2
Oxygen Desaturation Index (ODI) is a measure of OSA severity. The ODI will be determined by the ODI score at Visit 1 and Visit 2 as compared with to baseline
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2
The CGI-I is a seven point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Plan to share: Undecided
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Technical University of Munich →