Apnea Hypopnea Index Severity Versus Head Position During Sleep

NCT04086407 | Completed Results

• 1 other identifier: Apnea Guard - 1400
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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)

  8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

• 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)

  8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

• 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

  8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

• 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

  8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Study Arms (1)

Forehead sensor recording precision head pitch and roll angle

EXPERIMENTAL

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.

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

Interventions

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

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.

Forehead sensor recording precision head pitch and roll angle

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sleep Systems: lead
• New England IRB: collaborator
• Mass Lung and Allergy, PC: collaborator

Study Sites (1)

Mass Lung and Allergy

Worcester, Massachusetts, 01605, United States

Location

Related Publications (19)

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  PMID: 18250205 BACKGROUND

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  PMID: 1798889 BACKGROUND

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  PMID: 4012159 BACKGROUND

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  PMID: 10084491 BACKGROUND

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  PMID: 20572416 BACKGROUND

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  PMID: 25515276 BACKGROUND

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  PMID: 21897774 BACKGROUND

• van Maanen JP, Richard W, Van Kesteren ER, Ravesloot MJ, Laman DM, Hilgevoord AA, de Vries N. Evaluation of a new simple treatment for positional sleep apnoea patients. J Sleep Res. 2012 Jun;21(3):322-9. doi: 10.1111/j.1365-2869.2011.00974.x. Epub 2011 Oct 22.

  PMID: 22017727 BACKGROUND

• Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):863-71. doi: 10.5664/jcsm.3956.

  PMID: 25126032 BACKGROUND

• Ravesloot MJL, White D, Heinzer R, Oksenberg A, Pepin JL. Efficacy of the New Generation of Devices for Positional Therapy for Patients With Positional Obstructive Sleep Apnea: A Systematic Review of the Literature and Meta-Analysis. J Clin Sleep Med. 2017 Jun 15;13(6):813-824. doi: 10.5664/jcsm.6622.

  PMID: 28212691 BACKGROUND

• van Kesteren ER, van Maanen JP, Hilgevoord AA, Laman DM, de Vries N. Quantitative effects of trunk and head position on the apnea hypopnea index in obstructive sleep apnea. Sleep. 2011 Aug 1;34(8):1075-81. doi: 10.5665/SLEEP.1164.

  PMID: 21804669 BACKGROUND

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  PMID: 29198296 BACKGROUND

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• Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.

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• Oksenberg A, Silverberg D, Offenbach D, Arons E. Positional therapy for obstructive sleep apnea patients: A 6-month follow-up study. Laryngoscope. 2006 Nov;116(11):1995-2000. doi: 10.1097/01.mlg.0000237674.66716.a7.

  PMID: 17075418 BACKGROUND

Related Links

• Informational website for positional treatment using head pitch and roll angles measuring AHI

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Operations
• Organization: Sleep Systems

e.lyons@sleepsystems-llc.com

978-835-7036

Study Officials

• Stacia Sailer, MD

  Mass Lung and Allergy

  PRINCIPAL INVESTIGATOR

• Payam Aghazzi, MD

  Mass Lung and Allergy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subject data is randomized to Investigator
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 11, 2019
• Study Start: November 28, 2016
• Primary Completion: November 19, 2017
• Study Completion: November 30, 2017
• Last Updated: June 30, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available immediately after publication. No end date
• Access Criteria: Requesters will be required to sign a Data Access Agreement

Locations

US (1)