Comparison of a Demand Oxygen Delivery

NCT06609694 | Recruiting FDA Device

• 2 other identifiers: 2022-0821R61HL165366
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Conditions

Obstructive Apnea

Keywords

Sleep Apnea; Down Syndrome; Continuous Positive Airway Pressure (CPAP)

Outcome Measures

Primary Outcomes (1)

• Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour

  Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour

  6 months

Secondary Outcomes (5)

• Value of Oxygen Saturation (SpO2)

  6 months

• Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%

  6 months

• Pulse Rate during sleep

  6 months

• Frequency of apnea happening during sleep

  6 months

• Total hours of Sleep Time

  6 months

Study Arms (2)

Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)

EXPERIMENTAL

The aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow.

Device: Portable oxygen concentrator Inogen G5 model

Reducing the frequency of obstructive apnea (Main study)

EXPERIMENTAL

The arm of the main study is still under development

Device: Portable oxygen concentrator Inogen G5 model

Interventions

Portable oxygen concentrator Inogen G5 model DEVICE

The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.

Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study); Reducing the frequency of obstructive apnea (Main study)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 5-17 years with or without Down Syndrome (DS).
• Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
• Absence of clinically significant hypoxia defined as oxygen saturation \< 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.

You may not qualify if:

• Current CPAP use with documented compliance (\> 4 hrs/ night; \> 70% of nights).
• Oxygen saturation \< 90% at rest during wakefulness
• Chronic daytime or nighttime use of supplemental oxygen.
• Unable to participate in a Polysomnogram (PSG).
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (10)

• Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002 Jan 30;21(2):231-45. doi: 10.1002/sim.1012.

  PMID: 11782062 BACKGROUND

• Chamseddin BH, Johnson RF, Mitchell RB. Obstructive Sleep Apnea in Children with Down Syndrome: Demographic, Clinical, and Polysomnographic Features. Otolaryngol Head Neck Surg. 2019 Jan;160(1):150-157. doi: 10.1177/0194599818797308. Epub 2018 Aug 28.

  PMID: 30149781 RESULT

• Lee CF, Lee CH, Hsueh WY, Lin MT, Kang KT. Prevalence of Obstructive Sleep Apnea in Children With Down Syndrome: A Meta-Analysis. J Clin Sleep Med. 2018 May 15;14(5):867-875. doi: 10.5664/jcsm.7126.

  PMID: 29734982 RESULT

• Waters KA, Castro C, Chawla J. The spectrum of obstructive sleep apnea in infants and children with Down Syndrome. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109763. doi: 10.1016/j.ijporl.2019.109763. Epub 2019 Nov 1.

  PMID: 31704574 RESULT

• Nerfeldt P, Sundelin A. Obstructive sleep apnea in children with down syndrome - Prevalence and evaluation of surgical treatment. Int J Pediatr Otorhinolaryngol. 2020 Jun;133:109968. doi: 10.1016/j.ijporl.2020.109968. Epub 2020 Feb 26.

  PMID: 32126418 RESULT

• Shete MM, Stocks RM, Sebelik ME, Schoumacher RA. Effects of adeno-tonsillectomy on polysomnography patterns in Down syndrome children with obstructive sleep apnea: a comparative study with children without Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):241-4. doi: 10.1016/j.ijporl.2009.11.006. Epub 2010 Jan 25.

  PMID: 20097432 RESULT

• MacDonagh L, Farrell L, O'Reilly R, McNally P, Javadpour S, Cox DW. Efficacy and adherence of noninvasive ventilation treatment in children with Down syndrome. Pediatr Pulmonol. 2021 Jun;56(6):1704-1715. doi: 10.1002/ppul.25308. Epub 2021 Mar 17.

  PMID: 33730448 RESULT

• Trucco F, Chatwin M, Semple T, Rosenthal M, Bush A, Tan HL. Sleep disordered breathing and ventilatory support in children with Down syndrome. Pediatr Pulmonol. 2018 Oct;53(10):1414-1421. doi: 10.1002/ppul.24122. Epub 2018 Jul 10.

  PMID: 29992744 RESULT

• Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020.

  PMID: 33194886 RESULT

• Dudoignon B, Amaddeo A, Frapin A, Thierry B, de Sanctis L, Arroyo JO, Khirani S, Fauroux B. Obstructive sleep apnea in Down syndrome: Benefits of surgery and noninvasive respiratory support. Am J Med Genet A. 2017 Aug;173(8):2074-2080. doi: 10.1002/ajmg.a.38283. Epub 2017 May 24.

  PMID: 28544488 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Down Syndrome

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Raouf Amin, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzie Hicks, BS

CONTACT

513-636-4944; suzie.hicks@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The aim of this study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow. This aim will be accomplished by a randomized crossover study design.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: September 24, 2024
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year
• Access Criteria: Pending

Locations

US (1)