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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: No Humidification; Device: Heated humidification (ThermoSmart)

• Registration Number: NCT01742949
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2017-06-08
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-05
• Last Update Submitted: 2019-05-05
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No humidification	No Humidification	Subjects use dry CPAP / APAP
Thermosmart	Heated humidification (ThermoSmart)	Subjects receive heated humidification

Primary Outcome Measures

Name	Time	Method
Adherence	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

Name	Time	Method
Epworth Sleepiness Score	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.
Subjective Dry Nose	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.
Preference	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.
Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)	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.
Subjective Dry Mouth	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.
Subjective Sinusitis	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.

Trial Locations

Locations (4)

Hôpital Bichat-Claude Bernard; 🇫🇷 Paris, Paris Cedex, France

Hôpital La Pitie Salpetriere; 🇫🇷 Paris, France

Hôpital Louis Mourier; 🇫🇷 Paris, France

Hôpital Henri Mondor; 🇫🇷 Paris, France