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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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 6, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
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 Intervention
Obstructive Sleep Apnea Device: Heated humidification (ThermoSmart)

Study Type: Interventional
Study Design: 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

Further study details as provided by Fisher and Paykel Healthcare:

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

Enrollment: 40
Study Start Date: October 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thermosmart
Subjects receive heated humidification
Device: Heated humidification (ThermoSmart)
Placebo Comparator: No humidification
Subjects use dry CPAP / APAP
Device: Heated humidification (ThermoSmart)


Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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
  Contacts and Locations
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

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
Principal Investigator: Marie-Pia D'Dortho, MD Hôpital Bichat-Claude Bernard
  More Information

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01742949     History of Changes
Other Study ID Numbers: FPH-TS2012
First Submitted: December 3, 2012
First Posted: December 6, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2014

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