Neostigmine For Snoring During DISE

Early Phase 1

Terminated

• Conditions: Snoring
• Interventions: Drug: Neostigmine Methylsulfate

• Registration Number: NCT03316963
• Lead Sponsor: Emory University

Brief Summary

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring.

Detailed Description

Snoring is a major problem, affecting 40 million Americans. The disease affects patient and partner sleep quality as well as daytime function. Snoring treatment is limited by device compliance (mouth appliance, positive airway pressure) and insurance does not regularly pay for these devices. Surgical treatment for snoring has mixed results. As a result, there is an important need to develop new treatments for snoring.

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring. If successful, development of a topical (non-injectable) version of this drug will be considered, so that the patient can apply him/herself before bedtime.

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Study Start: 2017-11-14
• Primary Completion: 2019-03-19
• Study Completion: 2019-03-19
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Snoring or mild obstructive sleep apnea
• English-speaking
• Greater than 18 years old
• Able to give informed consent

Read More

Exclusion Criteria

• On active anti-coagulation medication
• Pregnant women
• Hypersensitivity to neostigmine
• Peritonitis or mechanical obstruction of the intestinal or urinary tract
• Coronary artery disease
• Cardiac arrhythmia
• Recent acute coronary syndrome
• Myasthenia gravis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug-induced sleep endoscopy (DISE) with Neostigmine	Neostigmine Methylsulfate	Artificial sleep will be induced by intravenous administration of propofol with micro boluses until clinical sleep is achieved with spontaneous respiration and observed apneas under monitored anesthesia care. Endoscopy will be performed with visualization on a monitor and recording on a digital recorder. After the patient demonstrates snoring and obstruction collapse, the patient will receive the study medication (neostigmine methylsulfate 1mg/mL) into the soft palate.

Primary Outcome Measures

Name	Time	Method
Change in decibel sound after injection of neostigmine	The DISE will occur up to 30 days after the pre-op visit and study enrollment	The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Prior to the neostigmine injection, a snoring microphone will be placed over the right clavicle. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine sound emanating from the soft palate. Total run time, instantaneous decibel levels, LAeq (average decibel level over time), and the maximum decibel level will be recorded.
Change in soft palate motion after injection of neostigmine	The DISE will occur up to 30 days after the pre-op visit and study enrollment	The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine vibration emanating from the soft palate.

Trial Locations

Locations (1)

Raj C. Dedhia; 🇺🇸 Atlanta, Georgia, United States