This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments thermosmart, without thermosmart
Sponsor Fisher and Paykel Healthcare
Start date June 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02423681, CIA-101


To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(Active Comparator)
Subjects receive heated humidification as first intention with ThermoSmart
Heated humidification as first intention (HH1st) with ThermoSmart
(Placebo Comparator)
Subjects will receive no humidification. However they can be switched to the humidification group if patients complains of nasal dryness, congestion, nose bleed or if they had significant leak that cannot be resolved by two changes of mask.
without thermosmart
ThermoSmart is switched off

Primary Outcomes

Overall cost of equipment
time frame: 6 months
Number and type of additional interventions
time frame: 6 months
Duration of appointments
time frame: 6 months
Number of unplanned follow-ups
time frame: 6 months

Secondary Outcomes

Adherence to therapy
time frame: 6 months
Therapy Acceptance
time frame: 6 months
Apnea Hypopnea Index (AHI)
time frame: 6 months
time frame: 6 months
Side effects and symptoms reported
time frame: 6 months
Self-reported satisfaction
time frame: 6 months
Patient sleeping environment temperature and humidity
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Older than 18 years of age - Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI > 5 with significant daytime sleepiness) - Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years. - Fluent in spoken and written English Exclusion Criteria: - Significant uncontrolled cardiac disease, as per the principal investigator's discretion - Co-existing lung disease, as per the principal investigator's discretion - Co-existing sleep disorder, such a predominant central sleep apnoea - Pregnancy - Participants that are unable or unwilling to give informed consent.

Additional Information

Official title Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
Principal investigator Sara Parsons, Chief Clinical Physiologist
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fisher and Paykel Healthcare.