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

February 13, 2017 updated by: Fisher and Paykel Healthcare

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom
        • Lung Function and Sleep Unit, St George's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Heated humidification as first intention (HH1st)
Subjects receive heated humidification as first intention with ThermoSmart
Heated humidification as first intention (HH1st) with ThermoSmart
Placebo Comparator: Non-heated humidification
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.
ThermoSmart is switched off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cost of equipment
Time Frame: 6 months
(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
6 months
Number and type of additional interventions
Time Frame: 6 months
The number and type of additional interventions (masks, nasal steroids) and the associated cost
6 months
Duration of appointments
Time Frame: 6 months
Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)
6 months
Number of unplanned follow-ups
Time Frame: 6 months
number of unplanned follow-ups
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to therapy
Time Frame: 6 months
Compliance data from the device
6 months
Therapy Acceptance
Time Frame: 6 months
Number of withdrawals and drop out from the therapy
6 months
Apnea Hypopnea Index (AHI)
Time Frame: 6 months
AHI to measure the treatment efficacy
6 months
Leak
Time Frame: 6 months
Total system leak from the device
6 months
Side effects and symptoms reported
Time Frame: 6 months
Any side effects and symptoms reported with the therapy
6 months
Self-reported satisfaction
Time Frame: 6 months
Self-reported satisfaction via treatment questionnaires
6 months
Patient sleeping environment temperature and humidity
Time Frame: 6 months
The temperature and humidity of the patient's environment as measured by a humidity logger
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sara Parsons, Chief Clinical Physiologist, Lung Function and Sleep Unit, St George's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 19, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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