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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02423681
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: ThermoSmart Device: Without ThermoSmart Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Heated humidification as first intention (HH1st)
Subjects receive heated humidification as first intention with ThermoSmart
 Device: 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.
 Device: Without ThermoSmart
ThermoSmart is switched off


Outcome Measures
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Primary Outcome Measures :
  1. Overall cost of equipment [ Time Frame: 6 months ]
    (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables

  2. Number and type of additional interventions [ Time Frame: 6 months ]
    The number and type of additional interventions (masks, nasal steroids) and the associated cost

  3. 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)

  4. Number of unplanned follow-ups [ Time Frame: 6 months ]
    number of unplanned follow-ups


Secondary Outcome Measures :
  1. Adherence to therapy [ Time Frame: 6 months ]
    Compliance data from the device

  2. Therapy Acceptance [ Time Frame: 6 months ]
    Number of withdrawals and drop out from the therapy

  3. Apnea Hypopnea Index (AHI) [ Time Frame: 6 months ]
    AHI to measure the treatment efficacy

  4. Leak [ Time Frame: 6 months ]
    Total system leak from the device

  5. Side effects and symptoms reported [ Time Frame: 6 months ]
    Any side effects and symptoms reported with the therapy

  6. Self-reported satisfaction [ Time Frame: 6 months ]
    Self-reported satisfaction via treatment questionnaires

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423681


Locations
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United Kingdom
Lung Function and Sleep Unit, St George's Hospital
London, United Kingdom
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Sara Parsons, Chief Clinical Physiologist Lung Function and Sleep Unit, St George's Hospital
More Information
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02423681    
Other Study ID Numbers: CIA-101
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases