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Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

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ClinicalTrials.gov Identifier: NCT01742949
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Heated humidification (ThermoSmart) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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Arm Intervention/treatment
Active Comparator: Thermosmart
Subjects receive heated humidification
Device: Heated humidification (ThermoSmart)
Placebo Comparator: No humidification
Subjects use dry CPAP / APAP
Device: Heated humidification (ThermoSmart)



Primary Outcome Measures :
  1. Adherence [ Time Frame: 8 weeks ]
    Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device.


Secondary Outcome Measures :
  1. Acceptance [ Time Frame: 8 weeks ]
    Acceptance / drop-out rate, leak, ESS score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years of age
  • Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
  • Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
  • Patients receiving social security coverage (excluding MEAs)
  • Fluent spoken and written French

Exclusion Criteria:

  • Severe heart disease
  • Co-existing lung disease
  • Co-existing sleep disorder
  • Pregnant
  • Refused participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742949


Locations
France
Hôpital Bichat-Claude Bernard
Paris, Paris Cedex, France, 75877
Hôpital Henri Mondor
Paris, France
Hôpital La Pitie Salpetriere
Paris, France
Hôpital Louis Mourier
Paris, France
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Marie-Pia D'Dortho, MD Hôpital Bichat-Claude Bernard

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01742949     History of Changes
Other Study ID Numbers: FPH-TS2012
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014

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