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

NCT02639884 | Completed Results FDA Device

• 1 other identifier: DROV0007
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (2)

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

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

  One visit

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

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

  One visit

Study Arms (1)

Evaluation Group

EXPERIMENTAL

All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring

Device: SedLine EEG; Device: RRa monitoring

Interventions

SedLine EEG DEVICE

Evaluation Group

RRa monitoring DEVICE

Evaluation Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo Corporation

vramakanth@masimo.com

9492977416

Study Officials

• David R Drover, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 28, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 2, 2021
• Results First Posted: April 2, 2021

Record last verified: 2021-03

Locations

US (1)