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

Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Heated humidification (ThermoSmart); Device: No Humidification

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hopital Henri Mondor
  • Paris, France
    • Hôpital La Pitié Salpêtrière
  • Paris, France
    • Hopital Louis Mourier
  • Paris Cedex
    • Paris, Paris Cedex, France, 75877
      • Hopital Bichat-Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Score	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.	8 weeks
Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)	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.	8 weeks
Subjective Dry Nose	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.	8 weeks
Subjective Dry Mouth	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.	8 weeks
Subjective Sinusitis	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.	8 weeks
Preference	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.	8 weeks

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Marie-Pia D'Dortho, MD, Hopital Bichat-Claude Bernard

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 5, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: FPH-TS2012