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N/A N=8 Basic Science

Apnea Hypopnea Index Severity Versus Head Position During Sleep

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

Bottom Line

View on ClinicalTrials.gov: NCT04086407 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement — 8 Participants — p=<.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Dual-axis inclinometer attached to the subject's forehead with tape (Device)
Age
Adult · 21+ yrs
Sex
All
Sponsor
Sleep Systems
Primary completion
Nov 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement		 8 <.05 sig
PRIMARY
Number of Participants With SpO2 Desaturation Severity Improvement		 8 <.05 sig
PRIMARY
Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor		 8 —
PRIMARY
Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor		 8 <.05 sig

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.

Eligibility Criteria

Inclusion Criteria

  • Participant has provided written informed consent
  • Participant is diagnosed with Positional Obstructive Sleep Apnea
  • Participant age is between 21 and 60 years
  • If currently on Positive Air Pressure (PAP) therapy, is able to produce compliance data within the last week before screening visit
  • Is able to follow directions during the overnight sleep study
  • If currently on PAP therapy participant self-report that excessive daytime sleepiness persists when PAP therapy is not in use
  • Able to be of "PAP" therapy for 4 nights

Exclusion Criteria

  • Documented diagnosis of Insomnia
  • Chronic ear infections
  • Persistent neck "pains"
  • Persistent chronic posture physical issues
  • Previous C-Spine fusion
  • History of Cardiac Arrythmia
  • History of seizures
  • Allergic to Standard Tape used in Sleep Centers
  • Non-English speaking.
  • Hospitalization within the previous 4 weeks
  • Use of antibiotics or steroids within the previous 4 weeks
  • Any major uncontrolled disease or condition, such as congestive heart failure, malignancy, end-stage heart disease, end-stage heart disease. Arterial Laterial Sclerosis (ALS), or sever stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and/or participant reported medical history
  • History of severe osteoporosis
  • Excessive alcohol intake (> 6oz hard liquor, 48 oz beer or 20 oz wine daily), or illicit drug use by review of medical history and/or participant reported medical history
  • Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04086407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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