- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03316963
Neostigmine For Snoring During DISE
Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Raj C. Dedhia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in decibel sound after injection of neostigmine
Time Frame: The DISE will occur up to 30 days after the pre-op visit and study enrollment
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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.
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The DISE will occur up to 30 days after the pre-op visit and study enrollment
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Change in soft palate motion after injection of neostigmine
Time Frame: The DISE will occur up to 30 days after the pre-op visit and study enrollment
|
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.
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The DISE will occur up to 30 days after the pre-op visit and study enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raj C. Dedhia, MD MS, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Respiratory
- Respiratory Sounds
- Snoring
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Cholinesterase Inhibitors
- Parasympathomimetics
- Neostigmine
Other Study ID Numbers
- IRB00096770
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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