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Behavioural Intervention
Therapy arm for Sleep Apnea
N/A
Waitlist Available
Research Sponsored by Signifier Medical Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between pre-therapy (day 7) and post therapy (day 49)
Awards & highlights
No Placebo-Only Group
Summary
This trial will help to improve our understanding of how the eXciteOSA device affects snoring and sleep apnoea and will provide valuable information on whether this new device is an effective treatment for these conditions.
Eligible Conditions
- Sleep Apnea
- Snoring
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between pre-therapy (day 7) and post therapy (day 49)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between pre-therapy (day 7) and post therapy (day 49)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Snoring
Change in sleep disordered breathing indices - Apnea Hypopnea Index (AHI)
Change in sleep disordered breathing indices - Oxygen Desaturation Index (ODI)
Secondary study objectives
Comparison of quality of life questionnaires at start and end of therapy - EQ-5D-5L
Comparison of sleep quality questionnaires at start and end of therapy - Epsworth Sleepiness Score (ESS)
Comparison of sleep quality questionnaires at start and end of therapy - Pittsburgh Sleep Quality Index (PSQI)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Therapy armExperimental Treatment1 Intervention
Six week use of eXciteOSA device. Once daily for 20 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eXciteOSA
2022
N/A
~110
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Who is running the clinical trial?
Signifier Medical TechnologiesLead Sponsor
3 Previous Clinical Trials
279 Total Patients Enrolled
Jessie P Bakker, PhDStudy DirectorSignifier Medical Technologies
2 Previous Clinical Trials
164 Total Patients Enrolled
Yasser ZayniStudy DirectorSignifier Medical Technologies
2 Previous Clinical Trials
164 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had oral surgery in the past to treat snoring.You have significant abnormalities in the structure of your face, such as a small jaw or a rare facial condition.You have ongoing issues with your nose, such as a deviated septum, nasal polyps, or chronic sinus problems that cause symptoms.Your tonsils are very large (Grade 3 or higher).You have a pacemaker or any implanted medical device that uses electricity.You have been complaining about snoring for more than six months.You have a body mass index (BMI) of more than 35, which means you are severely overweight.You are female or male, aged 18 years or above.You have a tongue or lip piercing.
Research Study Groups:
This trial has the following groups:- Group 1: Therapy arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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