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

This study is currently recruiting participants.
Verified November 2013 by Fisher and Paykel Healthcare
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT01742949
First received: December 3, 2012
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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
Diagnosed With OSA and Eligible for CPAP Treatment
Naïve to CPAP Therapy
Initial Proscription of a Nasal Mask
Device: Heated humidification (ThermoSmart)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Acceptance / drop-out rate, leak, ESS score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742949

Contacts
Contact: Marie-Pia D'Dortho, MD +33 1 40 25 80 80 marie-pia.dortho@bch.aphp.fr

Locations
France
Hôpital Bichat-Claude Bernard Recruiting
Paris, Paris Cedex, France, 75877
Contact: Marie-Pia d'Ortho, MD         
Principal Investigator: Marie-Pia d'Ortho, MD         
Sub-Investigator: Caroline Schaeffer         
Sub-Investigator: Maria Stoïca         
Hôpital La Pitie Salpetriere Recruiting
Paris, France
Contact: Carole Philippe, MD         
Principal Investigator: Carole Philippe, MD         
Hôpital Henri Mondor Recruiting
Paris, France
Contact: Xavier Drouot, MD         
Principal Investigator: Xavier Drouot, MD         
Hôpital Louis Mourier Recruiting
Paris, France
Contact: Dominique Maillard    01 47 60 62 48    dominique.maillard@lmr.aphp.fr   
Principal Investigator: Dominique Maillard         
Sub-Investigator: Najet BOUACH         
Sponsors and Collaborators
Fisher and Paykel Healthcare
  More Information

No publications provided

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01742949     History of Changes
Other Study ID Numbers: FPH-TS2012
Study First Received: December 3, 2012
Last Updated: November 10, 2013
Health Authority: France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on April 15, 2014