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

This study has been completed.
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: June 21, 2015
Last verified: June 2015
  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:


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:
  • Epworth Sleepiness Score (ESS) [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness

  • Functional Outcome of Sleep Questionnaire (FOSQ) [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = "I don't do this activity for other reasons", 1="Yes extremely", 2="Yes moderately", 3= "Yes a little", 4 = "No". Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities.

  • Nasopharyngeal Complaints [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 ("no complaints") to 5 ("very strong"). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25.


Enrollment: 80
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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 a heated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517750

Locations
Germany
Helios - Klinik Ambrock
Hagen, Weg, Germany, 60
Sponsors and Collaborators
Fisher and Paykel Healthcare
Helios Klinik Ambrock
Investigators
Principal Investigator: Georg Nilius, Dr. Helios Klinik Ambrock
  More Information

Additional Information:
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
Results First Received: March 10, 2015
Last Updated: June 21, 2015
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:
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on July 30, 2015