Neostigmine For Snoring During DISE

Emory University

Status and phase: Terminated; Early Phase 1

Conditions: Snoring

Treatments: Drug: Neostigmine Methylsulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03316963

IRB00096770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Drug-induced sleep endoscopy (DISE) with Neostigmine

Experimental group

Description:

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.

Treatment:

Drug: Neostigmine Methylsulfate