- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02423681
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
Conditions
Intervention / Treatment
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
-
-
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London, United Kingdom
- Lung Function and Sleep Unit, St George's Hospital
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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
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Heated humidification as first intention (HH1st) with ThermoSmart
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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
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Number and type of additional interventions
Time Frame: 6 months
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The number and type of additional interventions (masks, nasal steroids) and the associated cost
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6 months
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Duration of appointments
Time Frame: 6 months
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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
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6 months
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Apnea Hypopnea Index (AHI)
Time Frame: 6 months
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AHI to measure the treatment efficacy
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6 months
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Leak
Time Frame: 6 months
|
Total system leak from the device
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6 months
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Side effects and symptoms reported
Time Frame: 6 months
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Any side effects and symptoms reported with the therapy
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6 months
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Self-reported satisfaction
Time Frame: 6 months
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Self-reported satisfaction via treatment questionnaires
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6 months
|
Patient sleeping environment temperature and humidity
Time Frame: 6 months
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The temperature and humidity of the patient's environment as measured by a humidity logger
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIA-101
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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