A Comparison of CPAP With and Without Humidification: A Pilot Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423681
• Other study ID #: CIA-101
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: February 13, 2017
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• ThermoSmart
Heated humidification as first intention (HH1st) with ThermoSmart
• Without ThermoSmart
ThermoSmart is switched off

Locations

Country	Name	City	State
United Kingdom	Lung Function and Sleep Unit, St George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cost of equipment	(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables	6 months
Primary	Number and type of additional interventions	The number and type of additional interventions (masks, nasal steroids) and the associated cost	6 months
Primary	Duration of appointments	Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)	6 months
Primary	Number of unplanned follow-ups	number of unplanned follow-ups	6 months
Secondary	Adherence to therapy	Compliance data from the device	6 months
Secondary	Therapy Acceptance	Number of withdrawals and drop out from the therapy	6 months
Secondary	Apnea Hypopnea Index (AHI)	AHI to measure the treatment efficacy	6 months
Secondary	Leak	Total system leak from the device	6 months
Secondary	Side effects and symptoms reported	Any side effects and symptoms reported with the therapy	6 months
Secondary	Self-reported satisfaction	Self-reported satisfaction via treatment questionnaires	6 months
Secondary	Patient sleeping environment temperature and humidity	The temperature and humidity of the patient's environment as measured by a humidity logger	6 months