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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

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.
 
ClinicalTrials.gov Identifier: NCT01742949
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
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) Device: No Humidification Not Applicable

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thermosmart
Subjects receive heated humidification
Device: Heated humidification (ThermoSmart)
Heated Humidification (ThermoSmart) Turned On

Placebo Comparator: No humidification
Subjects use dry CPAP / APAP
Device: No Humidification
Heated Humidification (ThermoSmart) Turn Off




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. Epworth Sleepiness Score [ Time Frame: 8 weeks ]
    Subjective measure of daytime sleepiness. There are 8 questions where the patient picks a scale of 0 = would never doze to 3 = high level of dozing for each questions. There can be a total score of 24. A score of 0-10 indicates normal daytime sleepiness, 11-12 mild excessive daytime sleepiness, 13-15 moderate excessive daytime sleepiness and 16-24 is severe excessive daytime sleepiness.

  2. Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) [ Time Frame: 8 weeks ]
    Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.

  3. Subjective Dry Nose [ Time Frame: 8 weeks ]
    Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms.

  4. Subjective Dry Mouth [ Time Frame: 8 weeks ]
    Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms.

  5. Subjective Sinusitis [ Time Frame: 8 weeks ]
    Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has "not at all" and on the right side of the scale has "extremely", In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms.

  6. Preference [ Time Frame: 8 weeks ]
    Through a questionnaire, the participant is asked to picked rather they prefer treatment A (No ThermoSmart) or treatment B (ThermoSmart). If they did not pick neither, it is considered no preference.



Information from the National Library of Medicine

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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
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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
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Principal Investigator: Marie-Pia D'Dortho, MD Hôpital Bichat-Claude Bernard
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01742949    
Other Study ID Numbers: FPH-TS2012
First Posted: December 6, 2012    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases