Neostigmine For Snoring During DISE

NCT03316963 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00096770
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring

Keywords

Neostigmine; Nerve stimulant medication; Treatments for snoring

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Drug-induced sleep endoscopy (DISE) with Neostigmine

EXPERIMENTAL

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

Interventions

Neostigmine Methylsulfate DRUG

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.

Drug-induced sleep endoscopy (DISE) with Neostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Raj C. Dedhia

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Snoring

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Raj C. Dedhia, MD MS

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asstant Professor

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: November 14, 2017
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-06

Locations

US (1)