N/A N=10 Randomized Triple-blind Treatment

Phamacological Reversal of Airway Instability During Sedation

Upper Airway Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT01171118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: AHI - Apnea Hypopnea Index — 14.5; 27.9; 11.3; 12.1 events per hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physostigmine (Drug); Oxygen (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of Rochester
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY AHI - Apnea Hypopnea Index	14.5; 27.9; 11.3; 12.1	—

Summary

The investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study in physostigmine versus placebo.

Eligibility Criteria

Inclusion Criteria

Ages 18-45
BMI below 25
Healthy males

Exclusion Criteria

Psychiatric illness
Substance abuse
Airway disorders
Bleeding abnormatlities
Claustrophobia
Sleep apnea.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01171118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.