SnoringEarly Phase 1NCT03316963
Neostigmine For Snoring During DISE
A Early Phase 1 study testing Neostigmine Methylsulfate in people with Snoring, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring
- What is being tested?
- Neostigmine Methylsulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 19 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Snoring or mild obstructive sleep apnea
- English-speaking
- Greater than 18 years old
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
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.
Read the 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
- Being tested
- Neostigmine Methylsulfate
- Keywords
- Neostigmine, Nerve stimulant medication, Treatments for snoring
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine MethylsulfateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neostigmine Methylsulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The DISE will occur up to 30 days after the pre-op visit and study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start14 Nov 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: PI is moving the a new institution and ended the study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Dedhia, Emory University
- Investigators
- Raj C. Dedhia, MD MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316963
- Sponsor's protocol ID
- IRB00096770
- Status last verified
- Jun 2019
- First submitted
- 18 Oct 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
- ClinicalTrials.gov ID
- NCT03316963
- Acronym / sponsor ID
- IRB00096770
- Conditions
- Snoring
- Keywords
- Neostigmine, Nerve stimulant medication, Treatments for snoring
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is moving the a new institution and ended the study early.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-induced sleep endoscopy (DISE) with Neostigmine | Experimental | Drug: Neostigmine MethylsulfateArtificial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Snoring or mild obstructive sleep apnea
- English-speaking
- Greater than 18 years old
- Able to give informed consent
Key exclusion criteria (8 listed)
- On active anti-coagulation medication
- Pregnant women
- Hypersensitivity to neostigmine
- Peritonitis or mechanical obstruction of the intestinal or urinary tract
- Coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine MethylsulfateAfter 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 | Drug-induced sleep endoscopy (DISE) with Neostigmine |
Primary outcome
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
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
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.
Results and safety
The study was stopped early (reason given: PI is moving the a new institution and ended the study early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj C. Dedhia, MD MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neostigmine Methylsulfate in people with Snoring, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI is moving the a new institution and ended the study early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.