3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea

NCT02261857 | Completed Early Phase 1

• 1 other identifier: HUM00078727
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether patient-specific computer-aided design (CAD) and three-dimensional (3D) printing can be utilized to produce personalized, effective continuous positive airway pressure (CPAP) masks for children with severe obstructive sleep apnea (OSA) and craniofacial anomalies who encounter significant difficulty using CPAP because of poorly fitting masks despite exhausting available commercial mask options.

Conditions

Sleep Apnea, Obstructive; Craniofacial Abnormalities; Pediatric Disorder

Keywords

Obstructive Sleep Apnea; Craniofacial Abnormalities; Pediatrics; Computer-Aided Design; Continuous Positive Airway Pressure; Three-Dimensional Printing; Additive Manufacturing

Outcome Measures

Primary Outcomes (4)

• Change in CPAP Compliance at 1 month

  Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Average hours usage will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value in hours per night.

  1 month

• Change in CPAP Leak Rate at 1 month

  Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Leak in liters per minute will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value in liters per minute.

  1 month

• Change in residual AHI on CPAP at 1 month

  Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Residual apnea-hypopnea index (AHI) will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical value denoting AHI.

  1 month

• Change in time spent in large leak on CPAP at 1 month

  Subject CPAP usage data will be downloaded from their CPAP machine before beginning the use to personalized mask (baseline) and after 1 month of consistent use of the personalized mask (1 month post-intervention). Percentage (%) time spent in large leak per night will be recorded and compared between baseline CPAP usage data and 1 month post-intervention CPAP usage data to assess efficacy of the personalized mask compared to the best prior alternative. Outcome will be measured as a numerical percentage as a percentage of total time spent in large leak per night over total time using CPAP per night.

  1 month

Secondary Outcomes (8)

• Change in Quality of Life via OSA-18 questionnaire

  1 month

• Safety outcomes: Comfort at baseline

  Baseline

• Safety outcomes: Comfort at 1 month

  1 month

• Safety outcomes: Skin reaction at 1 month

  1 month

• Change in Quality of Life via PSQ questionnaire

  1 month

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Intervention: Subjects will undergo assessment and a personalized CPAP mask device will be manufactured using patient-specific computer-aided design and 3D printing. The subject will use the personalized CPAP mask for 1 month of consistent use and post-intervention data will be collected for compare to historical control (see other arm)

Device: Personalized continuous positive airway pressure (CPAP) mask

Historical Control Arm

NO INTERVENTION

Pre-interventional baseline data on subject OSA, CPAP compliance, and quality of life (QoL) measures will be collected to serve as historical controls.

Interventions

Personalized continuous positive airway pressure (CPAP) mask DEVICE

Personalized CPAP mask manufactured for study subjects using a combination of patient-specific computer-aided design and three-dimensional printing

Intervention Arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• On-going need for CPAP therapy based on polysomnography
• Inability to tolerate CPAP attributed to poor fit by a sleep clinician
• The opinion of a sleep clinician that reasonable commercially available mask options have been exhausted
• Caregivers must also be proficient in English to complete standard questionnaires.

You may not qualify if:

• Subjects no longer needing CPAP therapy
• Subjects able to successfully use a commercially available mask.

Sponsors & Collaborators

• Glenn Green: lead
• American Academy of Otolaryngology-Head and Neck Surgery Foundation: collaborator
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (10)

• Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.

  PMID: 22926176 BACKGROUND

• Brunetti L, Rana S, Lospalluti ML, Pietrafesa A, Francavilla R, Fanelli M, Armenio L. Prevalence of obstructive sleep apnea syndrome in a cohort of 1,207 children of southern Italy. Chest. 2001 Dec;120(6):1930-5. doi: 10.1378/chest.120.6.1930.

  PMID: 11742924 BACKGROUND

• Amin RS, Kimball TR, Bean JA, Jeffries JL, Willging JP, Cotton RT, Witt SA, Glascock BJ, Daniels SR. Left ventricular hypertrophy and abnormal ventricular geometry in children and adolescents with obstructive sleep apnea. Am J Respir Crit Care Med. 2002 May 15;165(10):1395-9. doi: 10.1164/rccm.2105118.

  PMID: 12016102 BACKGROUND

• Duman D, Naiboglu B, Esen HS, Toros SZ, Demirtunc R. Impaired right ventricular function in adenotonsillar hypertrophy. Int J Cardiovasc Imaging. 2008 Mar;24(3):261-7. doi: 10.1007/s10554-007-9265-1. Epub 2007 Sep 6.

  PMID: 17846918 BACKGROUND

• Leung LC, Ng DK, Lau MW, Chan CH, Kwok KL, Chow PY, Cheung JM. Twenty-four-hour ambulatory BP in snoring children with obstructive sleep apnea syndrome. Chest. 2006 Oct;130(4):1009-17. doi: 10.1378/chest.130.4.1009.

  PMID: 17035432 BACKGROUND

• Luna-Paredes C, Anton-Pacheco JL, Garcia Hernandez G, Martinez Gimeno A, Romance Garcia AI, Garcia Recuero II. Screening for symptoms of obstructive sleep apnea in children with severe craniofacial anomalies: assessment in a multidisciplinary unit. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1767-70. doi: 10.1016/j.ijporl.2012.08.020. Epub 2012 Sep 11.

  PMID: 22980525 BACKGROUND

• Plomp RG, Bredero-Boelhouwer HH, Joosten KF, Wolvius EB, Hoeve HL, Poublon RM, Mathijssen IM. Obstructive sleep apnoea in Treacher Collins syndrome: prevalence, severity and cause. Int J Oral Maxillofac Surg. 2012 Jun;41(6):696-701. doi: 10.1016/j.ijom.2012.01.018. Epub 2012 Apr 20.

  PMID: 22521672 BACKGROUND

• Zandieh SO, Padwa BL, Katz ES. Adenotonsillectomy for obstructive sleep apnea in children with syndromic craniosynostosis. Plast Reconstr Surg. 2013 Apr;131(4):847-852. doi: 10.1097/PRS.0b013e3182818f3a.

  PMID: 23542256 BACKGROUND

• Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.

  PMID: 10733617 BACKGROUND

• Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254.

  PMID: 10889473 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Craniofacial Abnormalities

Interventions

Continuous Positive Airway Pressure; Masks

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Glenn E Green, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 10, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

US (1)