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Apnea Hypopnea Index Severity Versus Head Position During Sleep

NCT04086407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-06-30

Study results available
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Summary

This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.

Conditions

  • Sleep Disordered Breathing
  • Sleep Hypopnea
  • Sleep Apnea
  • Sleep Apnea, Obstructive
  • Snoring

Interventions

DEVICE

Dual-axis inclinometer attached to the subject's forehead with tape

This is the first clinical trial in the industry to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity. The apnea equation is based on the gravitational crush forces of the mass of the tongue and nearby tissue on the upper air way and is valid for most OSA sufferers.

Sponsors & Collaborators

  • New England IRB

    collaborator UNKNOWN

  • Mass Lung and Allergy, PC

    collaborator UNKNOWN

  • Sleep Systems

    lead INDUSTRY

Principal Investigators

  • Stacia Sailer, MD · Mass Lung and Allergy

  • Payam Aghazzi, MD · Mass Lung and Allergy

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2017-11-19
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086407 on ClinicalTrials.gov