Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04611750
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing
Status:
COMPLETED
Status Verified Date:
2022-02
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:
Currently, there is no pharmacological intervention for mild symptomatic obstructive sleep disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation (i.e. upper airway resistance syndrome), or mild sleep apnea. Here the investigators study the effect on SDB of stimulating pharyngeal muscles during sleep with AD036. The key hypothesis of the study is that AD036 is superior to placebo on self-reported and objective measures of SDB severity.
Detailed Description:
This is a randomized placebo-controlled 2-period crossover study. Each crossover period will consist of 14 days of QHS dosing of either AD036 or placebo, with a washout period of 7 days between each period.
Polysomnography will be performed at screening (baseline) and on the last dosing day of each of the two crossover dosing period.
The trial will enroll participants until a total of 24 responders are randomized into the crossover portion of the study.
Polysomnography will be performed at screening (baseline) and on the last dosing day of each of the two crossover dosing period.
The trial will enroll participants until a total of 24 responders are randomized into the crossover portion of the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: