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Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

This study is currently recruiting participants.
Verified January 2012 by Fisher and Paykel Healthcare
Sponsor:
Collaborator:
Helios Klinik Ambrock
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT01517750
First received: January 18, 2012
Last updated: January 22, 2012
Last verified: January 2012
History of Changes
  Purpose

Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the only technological advancements shown to increase adherence is heated humidification, now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to conventional humidification in reducing side effects, condensation and titrated pressure as well as increasing total sleep time. However, improved humidity delivery has not lead to significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.

A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a single blind, randomized, parallel-arm trial to determine whether the the use of heated humidification will impact therapy adherence.


Condition Intervention
Sleep Apnea, Obstructive
 Device: ICON Auto CPAP™ with Thermosmart heated tube
Device: ICON Auto CPAP™ without Thermosmart heated tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Therapy adherence with treatment per night averaged over total time period measured via internal software on the device and reported on using InfoSmart™ software with and without heated humidification. [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prediction of the need of humidification use before therapy. [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]

    Prediction of the need of humidification use before therapy. Which patients are likely to profit from heated humidification with tube heating.

    Acceptance rate, drop-out rate, leak, ESS score, Rhino FB score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score.



Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APAP with humidification
ICON Auto CPAP™ with Thermosmart heated tube
 Device: ICON Auto CPAP™ with Thermosmart heated tube
ICON Auto CPAP™ with heated humidification and the use of a heated tube
Active Comparator: APAP without humidification
ICON Auto CPAP™ without Thermosmart heated tube
 Device: ICON Auto CPAP™ without Thermosmart heated tube
ICON Auto CPAP™ without heated humidification or the use of e aheated tube.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with OSA
  • Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
  • Prescribed a nasal mask (as patients will be prescribed their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)

Exclusion Criteria:

  • Severe heart disease
  • Co-existing lung disease
  • Co-existing sleep disorders
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517750

Contacts
Contact: Hanie Shahpari, MSc +6495740123 ext 7909 hanie.shahpari@fphcare.co.nz

Locations
Germany
Helios - Klinik Ambrock Recruiting
Hagen, Weg, Germany, 60
Contact: Ulrike Domanski     +49 2331 974 2080     ulrike.domanski@helios-kliniken.de    
Sponsors and Collaborators
Fisher and Paykel Healthcare
Helios Klinik Ambrock
Investigators
Principal Investigator: Georg Nilius, Dr. Helios Klinik Ambrock
  More Information

Additional Information:
Sponsor Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01517750     History of Changes
Other Study ID Numbers: FPH-OSA-TS-2012
Study First Received: January 18, 2012
Last Updated: January 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Food Safety Authority

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure
ICON
ThermoSmart

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013