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OpenTrials
Completed

NCT Number: NCT02639884

Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG

Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
  • Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.

Exclusion criteria

  • ASA classification higher than III.
  • Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
  • Inability to obtain any physiological, vital, demographics and real time anaesthesia data
  • Subjects who have known intolerance to any of the drugs to be used according to the study protocol
  • Subjects deemed not suitable for study at the discretion of the Principal Investigator.

Treatment and study plan

SedLine EEG

Device

RRa monitoring

Device

Primary outcomes

  1. Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected

    Time frame: One visit

    Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.

  2. Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected

    Time frame: One visit

    All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2015
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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