Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263770
Status:
COMPLETED
Last Update Posted:
2011-05-20
First Post:
2005-12-07
Brief Title:
Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea
Detailed Description:
Obstructive sleep apnea OSA frequently associated with disruptive snoring is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important factor in impaired daytime executive function as well as cardiovascular disease risk Along with an increase in its recognition and diagnosis have come a growing pool of patients with milder disease and the associated challenge of ideal management Positive airway pressure PAP is well established as the mainstay of treatment for OSA since it is effective at reversing daytime neurocognitive sequelae and may be a useful adjunct to therapy in those with cardiovascular disease coexisting with OSA In patients with mild OSA however the response to PAP therapy appears muted which is related in part to poor adherence to treatment In response a number of alternative treatments have evolved The most recent innovation is soft palatal implants which in non-randomized uncontrolled studies have demonstrated reasonable efficacy in the treatment of snoring and mild to moderate OSA How the implants compare with standard therapy and their effect on cardiovascular variables are unknown Because of the ease and rapidity with which this system is implanted and because treatment effect is independent of patient compliance there is high potential for widespread use in patients with milder OSA We therefore are conducting a randomized placebo-controlled clinical trial to compare the impact of palatal implants with PAP on sleep disordered breathing daytime symptoms and blood pressure as well as patient bed partner acceptance
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5591559902 | None | None | None |