Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519149
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Effectiveness of Slow Wave Device for the Treatment of 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:
None
Brief Summary:
This is a safety and efficacy trial for a Slow Wave Inc UASD oral appliance for the treatment of Obstructive Sleep Apnea This trial will recruit 60-80 participants through our IRB partner Each participant will take pre-trial and post trail sleep studies and be measured before throughout and after the trial for Apnea-Hypopnea Index AHI Oxygen Desaturation Index ODI pulse rate to determine level of sleep improvement while wearing the device Safety will also be measured through survey dental exams and adverse events monitoring Patients will wear an O2 monitoring ring throughout the study and upload results daily Primary Objectives will evaluate AHI and ODI between sleep studies Secondary outcomes will compare the daily ring data to these two sleep studies to evaluate changes over time Patients will have the opportunity to complete daily diaries on their sleep experiences
Detailed Description:
This study is a single-center single-arm open label study to evaluate the safety and effectiveness of the Slow Wave UASD sleep and snore device in individuals with mild-to-moderate Obstructive Sleep Apnea OSA and individuals with severe OSA of less than 40 AHI events per hour who are not able to tolerate CPAP treatment
All participants will be given and initial Home Sleep Apnea Test HSAT to establish baseline readings for Number of OSA events during sleep average O2 score during sleep average pulse rate and Oxygen desaturation events of more than 4 during sleep ODI The initial HSAT will also determine if the patients have OSA
All participants will get an intraoral scan with a closed bite by a study partner The 3D scan will be used to create a personalized Slow Wave UASD device that will be used throughout the study Each participant will wear the device for a 90-day period Each participant will be given a WellUE O2 ring to wear every night throughout the study The ring connects to the WellUE application that participants will be asked to download to their phones The O2 ring application collects much of hte same data as is collected in a home sleep study Participants will be asked to upload the ring results to a study-managed database on a daily basis Ring results will be presented as secondary objectives in this trial The failure of a participant to send ring data will not disqualify them from the trial as primary objectives are the comparison of beginning and ending HSAT results Patients will be given patient health questionnaires and physical examinations prior to participation
All participants will be given and initial Home Sleep Apnea Test HSAT to establish baseline readings for Number of OSA events during sleep average O2 score during sleep average pulse rate and Oxygen desaturation events of more than 4 during sleep ODI The initial HSAT will also determine if the patients have OSA
All participants will get an intraoral scan with a closed bite by a study partner The 3D scan will be used to create a personalized Slow Wave UASD device that will be used throughout the study Each participant will wear the device for a 90-day period Each participant will be given a WellUE O2 ring to wear every night throughout the study The ring connects to the WellUE application that participants will be asked to download to their phones The O2 ring application collects much of hte same data as is collected in a home sleep study Participants will be asked to upload the ring results to a study-managed database on a daily basis Ring results will be presented as secondary objectives in this trial The failure of a participant to send ring data will not disqualify them from the trial as primary objectives are the comparison of beginning and ending HSAT results Patients will be given patient health questionnaires and physical examinations prior to participation
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