Apnea Hypopnea Index Severity Versus Head Position During Sleep

Sleep Apnea Clinical Trial

Official title:

The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086407
• Other study ID #: Apnea Guard - 1400
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2020
• Source: Sleep Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 30, 2017
• Est. primary completion date: November 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Mass Lung and Allergy	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Sleep Systems	Mass Lung and Allergy, PC, New England IRB

Country where clinical trial is conducted

United States, 

References & Publications (19)

Bignold JJ, Mercer JD, Antic NA, McEvoy RD, Catcheside PG. Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device. J Clin Sleep Med. 2011 Aug 15;7(4):376-83. doi: 10.5664/JCSM.1194. — View Citation

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Cartwright RD, Lloyd S, Lilie J, Kravitz H. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep. 1985;8(2):87-94. — View Citation

Eijsvogel MM, Ubbink R, Dekker J, Oppersma E, de Jongh FH, van der Palen J, Brusse-Keizer MG. Sleep position trainer versus tennis ball technique in positional obstructive sleep apnea syndrome. J Clin Sleep Med. 2015 Jan 15;11(2):139-47. doi: 10.5664/jcsm.4460. — View Citation

Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76. — View Citation

Gandotra K, May A, Auckley D. Variable Response to CPAP in a Case of Severe Obstructive Sleep Apnea: An Unusual Cause. J Clin Sleep Med. 2018 Jan 15;14(1):145-148. doi: 10.5664/jcsm.6904. — View Citation

Jokic R, Klimaszewski A, Crossley M, Sridhar G, Fitzpatrick MF. Positional treatment vs continuous positive airway pressure in patients with positional obstructive sleep apnea syndrome. Chest. 1999 Mar;115(3):771-81. — View Citation

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. — View Citation

Mador MJ, Kufel TJ, Magalang UJ, Rajesh SK, Watwe V, Grant BJ. Prevalence of positional sleep apnea in patients undergoing polysomnography. Chest. 2005 Oct;128(4):2130-7. — View Citation

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. — View Citation

Park JG, Ramar K, Olson EJ. Updates on definition, consequences, and management of obstructive sleep apnea. Mayo Clin Proc. 2011 Jun;86(6):549-54; quiz 554-5. doi: 10.4065/mcp.2010.0810. Review. — View Citation

Permut I, Diaz-Abad M, Chatila W, Crocetti J, Gaughan JP, D'Alonzo GE, Krachman SL. Comparison of positional therapy to CPAP in patients with positional obstructive sleep apnea. J Clin Sleep Med. 2010 Jun 15;6(3):238-43. — View Citation

Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG. Review. — View Citation

Ravesloot MJ, van Maanen JP, Dun L, de Vries N. The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea-a review of the literature. Sleep Breath. 2013 Mar;17(1):39-49. doi: 10.1007/s11325-012-0683-5. Epub 2012 Mar 24. Review. — View Citation

Ravesloot MJL, White D, Heinzer R, Oksenberg A, Pépin 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. Review. — View Citation

Safiruddin F, Koutsourelakis I, de Vries N. Analysis of the influence of head rotation during drug-induced sleep endoscopy in obstructive sleep apnea. Laryngoscope. 2014 Sep;124(9):2195-9. doi: 10.1002/lary.24598. Epub 2014 Mar 1. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (45° to 135°) as compared to non-supine (<20°above the horizon)	8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Primary	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 (45° to 135°) as compared to non-supine (<20°above the horizon)	8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Primary	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 = 20° 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 (45° to 135°) as compared to non-supine (<20°above the horizon) independent of torso position	8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Primary	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 = 20° 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 (45° to 135°) as compared to non-supine (<20°above the horizon) independent of torso position	8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

External Links

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