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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ThermoSmart
Without ThermoSmart
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Heated humidification as first intention (HH1st)

Non-heated humidification

Arm Description

Subjects receive heated humidification as first intention with ThermoSmart

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2015
Last Updated
February 13, 2017
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02423681
Brief Title
A Comparison of CPAP With and Without Humidification: A Pilot Study
Official Title
Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heated humidification as first intention (HH1st)
Arm Type
Active Comparator
Arm Description
Subjects receive heated humidification as first intention with ThermoSmart
Arm Title
Non-heated humidification
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ThermoSmart
Intervention Description
Heated humidification as first intention (HH1st) with ThermoSmart
Intervention Type
Device
Intervention Name(s)
Without ThermoSmart
Intervention Description
ThermoSmart is switched off
Primary Outcome Measure Information:
Title
Overall cost of equipment
Description
(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
Time Frame
6 months
Title
Number and type of additional interventions
Description
The number and type of additional interventions (masks, nasal steroids) and the associated cost
Time Frame
6 months
Title
Duration of appointments
Description
Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)
Time Frame
6 months
Title
Number of unplanned follow-ups
Description
number of unplanned follow-ups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence to therapy
Description
Compliance data from the device
Time Frame
6 months
Title
Therapy Acceptance
Description
Number of withdrawals and drop out from the therapy
Time Frame
6 months
Title
Apnea Hypopnea Index (AHI)
Description
AHI to measure the treatment efficacy
Time Frame
6 months
Title
Leak
Description
Total system leak from the device
Time Frame
6 months
Title
Side effects and symptoms reported
Description
Any side effects and symptoms reported with the therapy
Time Frame
6 months
Title
Self-reported satisfaction
Description
Self-reported satisfaction via treatment questionnaires
Time Frame
6 months
Title
Patient sleeping environment temperature and humidity
Description
The temperature and humidity of the patient's environment as measured by a humidity logger
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Parsons, Chief Clinical Physiologist
Organizational Affiliation
Lung Function and Sleep Unit, St George's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lung Function and Sleep Unit, St George's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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