CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Dual-axis inclinometer attached to the subject's forehead with tapedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04086407
NCT04086407N/ACompleted
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The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea

Sleep Systems·interventional·Posted Sep 11, 2019·Updated Jun 30, 2020

In Brief

A clinical study evaluating Dual-axis inclinometer attached to the subject's forehead with tape for Sleep Disordered Breathing and 4 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea, Sleep Apnea, Obstructive, Snoring
CountriesUnited States
CollaboratorsNew England IRB, Mass Lung and Allergy, PC

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 11, 2019
Enrollment StartNov 28, 2016
Primary CompletionNov 19, 2017
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.8 years ago

Interventions

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

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.