Neostigmine For Snoring During DISE
Primary Purpose
Snoring
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neostigmine Methylsulfate
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Neostigmine, Nerve stimulant medication, Treatments for snoring
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
Sites / Locations
- Raj C. Dedhia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug-induced sleep endoscopy (DISE) with Neostigmine
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03316963
Brief Title
Neostigmine For Snoring During DISE
Official Title
Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
PI is moving the a new institution and ended the study early.
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
Neostigmine, Nerve stimulant medication, Treatments for snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug-induced sleep endoscopy (DISE) with Neostigmine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Neostigmine Methylsulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in decibel sound after injection of neostigmine
Description
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.
Time Frame
The DISE will occur up to 30 days after the pre-op visit and study enrollment
Title
Change in soft palate motion after injection of neostigmine
Description
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.
Time Frame
The DISE will occur up to 30 days after the pre-op visit and study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj C. Dedhia, MD MS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raj C. Dedhia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
12. IPD Sharing Statement
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Neostigmine For Snoring During DISE
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