Neostigmine For Snoring During DISE

NCT ID: NCT03316963

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2019-03-19

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.

Conditions

Snoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-induced sleep endoscopy (DISE) with Neostigmine

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.

Group Type: EXPERIMENTAL

Neostigmine Methylsulfate

Intervention Type: 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.

Interventions

Neostigmine Methylsulfate

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Raj Dedhia

Asstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raj C. Dedhia, MD MS

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Raj C. Dedhia

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00096770

Identifier Type: -

Identifier Source: org_study_id