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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03316963
Other study ID # IRB00096770
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date November 14, 2017
Est. completion date March 19, 2019

Study information

Verified date June 2019
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 19, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Raj C. Dedhia Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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