Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655844
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extended Home-use Trial of a Novel Device to Reduce Chronic Pain
Status:
RECRUITING
Status Verified Date:
2024-10
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 study will investigate the effectiveness of the Sana Pain Reliever Sana PR at reducing chronic pain
The Sana PR is a device comprised of one main component Mask with Earbuds and two ancillary components Charger and Headband The device is worn over the eyes with earbuds in ears The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm Through the earbuds the device also plays different tones in conjunction with the pulses The device has a skin contacting Heart Rate Variability HRV sensor built into the forehead area that measures HRV throughout the use of the device
The system runs for 15 min at a time and is not FDA approved
The trial will last a total of 14 weeks
50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai
The Sana PR is a device comprised of one main component Mask with Earbuds and two ancillary components Charger and Headband The device is worn over the eyes with earbuds in ears The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm Through the earbuds the device also plays different tones in conjunction with the pulses The device has a skin contacting Heart Rate Variability HRV sensor built into the forehead area that measures HRV throughout the use of the device
The system runs for 15 min at a time and is not FDA approved
The trial will last a total of 14 weeks
50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai
Detailed Description:
None
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