Skip to main content
OpenTrials
Completed

NCT Number: NCT02423681

A Comparison of CPAP With and Without Humidification: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lung Function and Sleep Unit, St George's Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ThermoSmart

Device

Heated humidification as first intention (HH1st) with ThermoSmart

Without ThermoSmart

Device

ThermoSmart is switched off

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2015
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.