Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA

NCT00458406 | Completed Results

• 1 other identifier: 2007-1-5190
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is the usual treatment for children who do not improve following surgery. However, CPAP is uncomfortable and is often not tolerated. We therefore plan to study a modification of bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable. Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The secondary objective is to determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and determining which parameters predict adherence. Study Design/Setting/Participants: A single center, randomized controlled double-blind study of Bi-Flex vs CPAP use in children with OSAS over a 3 month period. Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study results, subjective questionnaire results. .

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; child; CPAP

Outcome Measures

Primary Outcomes (3)

• Minutes of Use Per Night at Month 1

  The number of minutes of use per night at month 1.

  1 month

• Minutes of Use Per Night at Month 3

  The number of minutes of use per night at Month 3.

  3 Months

• Change in Minutes of Use Per Night From Month 1 to Month 3

  minutes of use per night at Month 3 minus minutes of use per night at Month 1

  month 1, month 3

Secondary Outcomes (6)

• Drop Out Rate

  3 months

• Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3

  3 months

• Obstructive Sleep Apnea (OSA) 18 Score

  3 months

• Change in ESS From Month 1 to Month 3

  3 months

• Change in NOSE Scale Score From Month 1 to Month 3

  3 months

Study Arms (2)

Bi-Flex

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Following a baseline polysomnography, subjects in this arm will undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea will be randomized to Bi-Flex or CPAP, and repeat polysomnography will be performed on pressure at 3 months. Objective adherence data will be obtained at 1 and 3 months.

Device: Bi-Flex

CPAP

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo a clinical CPAP titration sleep study. Subjects in this arm received standard continuous positive airway pressure (CPAP) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea will randomized to CPAP or Bi-Flex, and repeat polysomnography will be performed on pressure at 3 months. Objective adherence data will be obtained at 1 and 3 months.

Device: CPAP

Interventions

Bi-Flex DEVICE

Bi-Flex: Subjects in this arm undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. Positive pressure used during sleep for 3 months

Also known as: BiPAP with Bi-Flex

Bi-Flex

CPAP DEVICE

CPAP: Subjects in this arm undergo standard continuous positive airway pressure (CPAP) therapy. Positive pressure used during sleep for 3 months.

Also known as: Continuous positive airway pressure

CPAP

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females aged 2 to 16 years.
• OSAS diagnosed on polysomnography.
• Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective.
• No plans for upper airway surgery in the next 3 months.

You may not qualify if:

• Age less than 2 years, as infants and toddlers have different pulmonary mechanics from older children, and may require intense behavioral modification programs prior to CPAP use.
• Age greater or equal to 16 years, as results may be similar to adult studies in these older patients.
• Previous use of CPAP / bilevel ventilation.
• Unable to read / understand English. -

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Philips Respironics: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (3)

• Marcus CL, Beck SE, Traylor J, Cornaglia MA, Meltzer LJ, DiFeo N, Karamessinis LR, Samuel J, Falvo J, DiMaria M, Gallagher PR, Beris H, Menello MK. Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children. J Clin Sleep Med. 2012 Feb 15;8(1):37-42. doi: 10.5664/jcsm.1656.

  PMID: 22334807 RESULT

• Marcus CL, Radcliffe J, Konstantinopoulou S, Beck SE, Cornaglia MA, Traylor J, DiFeo N, Karamessinis LR, Gallagher PR, Meltzer LJ. Effects of positive airway pressure therapy on neurobehavioral outcomes in children with obstructive sleep apnea. Am J Respir Crit Care Med. 2012 May 1;185(9):998-1003. doi: 10.1164/rccm.201112-2167OC. Epub 2012 Feb 9.

  PMID: 22323303 RESULT

• DiFeo N, Meltzer LJ, Beck SE, Karamessinis LR, Cornaglia MA, Traylor J, Samuel J, Gallagher PR, Radcliffe J, Beris H, Menello MK, Marcus CL. Predictors of positive airway pressure therapy adherence in children: a prospective study. J Clin Sleep Med. 2012 Jun 15;8(3):279-86. doi: 10.5664/jcsm.1914.

  PMID: 22701385 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

Limitations of the study include the relatively small sample size in the CPAP arm.

Results Point of Contact

• Title: Paul R. Gallagher, MA
• Organization: CTRC, Children's Hospital of Philadelphia

gallagherp@email.chop.edu

215-590-2739

Study Officials

• Carole L Marcus, M.B.B.Ch.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2007
• First Posted: April 10, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 2, 2019
• Results First Posted: April 1, 2014

Record last verified: 2019-09

Locations

US (1)