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

NCT01742949 | Completed Results DMC

• 1 other identifier: FPH-TS2012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Epworth Sleepiness Score

  8 weeks

• Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  8 weeks

• Subjective Dry Nose

  8 weeks

• Subjective Dry Mouth

  8 weeks

• Subjective Sinusitis

  8 weeks

Study Arms (2)

Thermosmart

ACTIVE COMPARATOR

Subjects receive heated humidification

Device: Heated humidification (ThermoSmart)

No humidification

PLACEBO COMPARATOR

Subjects use dry CPAP / APAP

Device: No Humidification

Interventions

Heated humidification (ThermoSmart) DEVICE

Heated Humidification (ThermoSmart) Turned On

Thermosmart

No Humidification DEVICE

Heated Humidification (ThermoSmart) Turn Off

No humidification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe heart disease
• Co-existing lung disease
• Co-existing sleep disorder
• Pregnant
• Refused participation

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (4)

Hôpital Bichat-Claude Bernard

Paris, Paris Cedex, 75877, France

Location

Hôpital Henri Mondor

Paris, France

Location

Hôpital La Pitie Salpetriere

Paris, France

Location

Hôpital Louis Mourier

Paris, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr Marie-Pia D'Ortho
• Organization: Hopital Bichat-Claude Bernard

marie-pia.dortho@bch.aphp.fr

+33140258080

Study Officials

• Marie-Pia D'Dortho, MD

  Hôpital Bichat-Claude Bernard

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Locations

FR (4)