Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559956
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOT-PSG
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 andor 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
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 andor 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None