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
Results First Received: March 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Sleep Apnea, Obstructive
Interventions: Device: ICON Auto CPAP™ with Thermosmart heated tube
Device: ICON Auto CPAP™ without Thermosmart heated tube

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
APAP Without Humidification + Low RIsks of NPC ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
APAP With Humidification + Low Risks of NPC ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
APAP With Humidification + High Risks of NPC ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
APAP Without Humidification + High RIsks of NPC ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.

Participant Flow:   Overall Study
    APAP Without Humidification + Low RIsks of NPC     APAP With Humidification + Low Risks of NPC     APAP With Humidification + High Risks of NPC     APAP Without Humidification + High RIsks of NPC  
STARTED     21     19     21     19  
COMPLETED     20     17     17     18  
NOT COMPLETED     1     2     4     1  
Lost to Follow-up                 1                 2                 4                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
APAP With Humidification + Low Risks of NPC ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
APAP Without Humidification + Low RIsks of NPC ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
APAP With Humidification + High Risks of NPC ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
APAP Without Humidification + High Risks of NPC ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
Total Total of all reporting groups

Baseline Measures
    APAP With Humidification + Low Risks of NPC     APAP Without Humidification + Low RIsks of NPC     APAP With Humidification + High Risks of NPC     APAP Without Humidification + High Risks of NPC     Total  
Number of Participants  
[units: participants]
  17     20     17     18     72  
Age  
[units: years]
Mean (Standard Deviation)
  51.6  (9.8)     54.3  (8.8)     50.9  (6.8)     52.1  (8.7)     52.3  (8.5)  
Gender  
[units: participants]
         
Female     2     5     4     4     15  
Male     15     15     13     14     57  
Region of Enrollment  
[units: participants]
         
Germany     17     20     17     18     72  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Epworth Sleepiness Score (ESS)   [ Time Frame: 6 weeks after patient randomization ]

3.  Secondary:   Functional Outcome of Sleep Questionnaire (FOSQ)   [ Time Frame: 6 weeks after patient randomization ]

4.  Secondary:   Nasopharyngeal Complaints   [ Time Frame: 6 weeks after patient randomization ]

5.  Post-Hoc:   Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries   [ Time Frame: 6 weeks after randomization ]

6.  Post-Hoc:   Adherence With ENT Surgeries   [ Time Frame: 6 weeks after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Georg Nilius
Organization: HELIOS-Klinik Ambrock
phone: +492331-9742005
e-mail: klinik-ambrock.pneumo@t-online.de


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