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Apnea Hypopnea Index Severity Versus Head Position During Sleep

Primary Purpose

Sleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual-axis inclinometer attached to the subject's forehead with tape
Sponsored by
Sleep Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Disordered Breathing

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Mass Lung and Allergy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Forehead sensor recording precision head pitch and roll angle

Arm Description

During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation.

Outcomes

Primary Outcome Measures

Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon)
Number of Participants With SpO2 Desaturation Severity Improvement
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in SpO2 de-saturation with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon)
Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon) independent of torso position
Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in SpO2 desaturation with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon) independent of torso position

Secondary Outcome Measures

Full Information

First Posted
August 29, 2019
Last Updated
June 16, 2020
Sponsor
Sleep Systems
Collaborators
New England IRB, Mass Lung and Allergy, PC
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1. Study Identification

Unique Protocol Identification Number
NCT04086407
Brief Title
Apnea Hypopnea Index Severity Versus Head Position During Sleep
Official Title
The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2016 (Actual)
Primary Completion Date
November 19, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sleep Systems
Collaborators
New England IRB, Mass Lung and Allergy, PC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Obstructive Sleep Apnea (OSA) is a common diagnosis in the general population, with a prevalence in the United States of 3-7% in men and 2-5% in women. It is defined as a sleep-related breathing disorder that results in decreased or complete cessation of airflow while the patient has ongoing breathing effort. It is well documented that trunk position significantly affects the severity of OSA. In fact, 50-75% of individuals with a diagnosis of OSA show supine predominance or worsened apnea-hypopnea index (AHI) when sleeping in the supine position. Positional Obstructive Sleep Apnea (POSA) is defined as an AHI ≥5 with >50% AHI reduction between the supine and non-supine positions and AHI. Studies show 49.5% of individuals with mild OSA (AHI 5-15), 19.4% with moderate OSA (AHI 15-30) and 6.5% in severe OSA (AHI > 30) had POSA. Due to this high prevalence of POSA, especially in the mild and moderate OSA populations, positional therapies have been developed and researched. In this clinical trial, if only the head position is considered, all subjects are positional sensitive and OSA severity can be calculated and consistently minimized by limiting the allowable range of head roll angle during sleep. Ten subjects underwent a standard polysomnography with an additional head angle sensor and coached to fall asleep in various head positions. Torso position was changed between supine and non-supine for a given head roll angle epoch to show the OSA severity change with torso position. Each sleep epoch of unique head pitch and roll angle was scored individually for AHI and Oxygen Saturation (SPO2) de-saturation. Investigators hypothesize that specific head roll angles independent of torso position will significantly reduce AHI and SpO2 desaturation severity in patients. The primary aim is to determine the head roll angles that significantly improve POSA independent of torso position. By doing this, Investigators believe to identify a "safe zone" of head roll angles that improve POSA and that can be used to support the development of head positional therapy for POSA patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea, Sleep Apnea, Obstructive, Snoring

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Subject data is randomized to Investigator
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forehead sensor recording precision head pitch and roll angle
Arm Type
Experimental
Arm Description
During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation.
Intervention Type
Device
Intervention Name(s)
Dual-axis inclinometer attached to the subject's forehead with tape
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement
Description
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon)
Time Frame
8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Title
Number of Participants With SpO2 Desaturation Severity Improvement
Description
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in SpO2 de-saturation with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon)
Time Frame
8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Title
Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor
Description
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon) independent of torso position
Time Frame
8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Title
Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor
Description
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in SpO2 desaturation with the head supine (45⁰ to 135⁰) as compared to non-supine (<20⁰above the horizon) independent of torso position
Time Frame
8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacia Sailer, MD
Organizational Affiliation
Mass Lung and Allergy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Payam Aghazzi, MD
Organizational Affiliation
Mass Lung and Allergy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mass Lung and Allergy
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual and group subject data for all primary outcome measures will be made available
IPD Sharing Time Frame
Data will be available immediately after publication. No end date
IPD Sharing Access Criteria
Requesters will be required to sign a Data Access Agreement
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Links:
URL
http://sleepsystems-llc.com
Description
Informational website for positional treatment using head pitch and roll angles measuring AHI

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Apnea Hypopnea Index Severity Versus Head Position During Sleep

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