NCT01485497

Brief Summary

The purpose of this study is to determine whether the Optical coherence tomography (OCT) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. The research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

August 2, 2011

Last Update Submit

October 28, 2022

Conditions

Sleep Apnea

Keywords

APNEA

Outcome Measures

Primary Outcomes (1)

  • obstructive upper airways in sleep disordered

    The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.

    8 hours

Study Arms (1)

3D endoscopic Fourier Domain OCT

OTHER

3D endoscopic Fourier Domain OCT

Device: 3D endoscopic Fourier Domain OCT

Interventions

3D endoscopic Fourier Domain OCTDEVICE

Evaluation of Obstructive Sleep Apnea

3D endoscopic Fourier Domain OCT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female age 18-65 years has no history of obstructive sleep apnea
  • Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
  • Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea

You may not qualify if:

  • Pregnant women.
  • Breastfeeding women.
  • Unable to understand or give consent to the study.
  • Currently taking drugs that are sensitive to light.
  • Currently taking routine anti-convulsion, sedative or antihistamine drugs.
  • Currently taking immuno-suppressive drug therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea SyndromesApnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Zhang, PhD

    UCI Beckman Laser Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jun Zhang, PhD, Assistant Project Scientist

Study Record Dates

First Submitted

August 2, 2011

First Posted

December 5, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 1, 2022

Record last verified: 2022-10