Neostigmine For Snoring During DISE

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy

Conditions
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Snoring

Intervention / Treatment
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* Drug: Neostigmine Methylsulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Snoring or mild obstructive sleep apnea English-speaking Greater than 18 years old Able to give informed consent 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-induced sleep endoscopy (DISE) with Neostigmine<br>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. | Drug: Neostigmine Methylsulfate<br>* After the patient demonstrates snoring and obstruction collapse, the patient will receive the study medication (neostigmine methylsulfate 1mg/mL) into the soft palate with co-administration of intravenous glycopyrrolate 0.2mg. At each of 5 injection sites on the soft palate , 0.5 mL (0.5mg) of neostigmine methylsulfate will be administered, yielding a total of 2.5mg (2.5mL) of neostigmine methylsulfate. The medication will be administered using five 1 mL syringes filled with 0.5 mL neostigmine each. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine both vibration and sound emanating from the soft palate. The anticipated time under sedation will be 14 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decibel sound after injection of neostigmine | 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. | The DISE will occur up to 30 days after the pre-op visit and study enrollment | 
| Change in soft palate motion after injection of neostigmine | 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. | The DISE will occur up to 30 days after the pre-op visit and study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neostigmine, Nerve stimulant medication, Treatments for snoring