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

• ClinicalTrials.gov Identifier: NCT02423681
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Last Update Posted: February 15, 2017
• Sponsor: Fisher and Paykel Healthcare
• Information provided by (Responsible Party): Fisher and Paykel Healthcare

Tracking Information

• First Submitted Date: April 15, 2015
• First Posted Date: April 22, 2015
• Last Update Posted Date: February 15, 2017
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2015)

• Overall cost of equipment [ Time Frame: 6 months ]
  (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
• Number and type of additional interventions [ Time Frame: 6 months ]
  The number and type of additional interventions (masks, nasal steroids) and the associated cost
• 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)
• Number of unplanned follow-ups [ Time Frame: 6 months ]
  number of unplanned follow-ups

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 19, 2015)

• Adherence to therapy [ Time Frame: 6 months ]
  Compliance data from the device
• Therapy Acceptance [ Time Frame: 6 months ]
  Number of withdrawals and drop out from the therapy
• Apnea Hypopnea Index (AHI) [ Time Frame: 6 months ]
  AHI to measure the treatment efficacy
• Leak [ Time Frame: 6 months ]
  Total system leak from the device
• Side effects and symptoms reported [ Time Frame: 6 months ]
  Any side effects and symptoms reported with the therapy
• Self-reported satisfaction [ Time Frame: 6 months ]
  Self-reported satisfaction via treatment questionnaires
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Obstructive Sleep Apnea

Intervention

• Device: ThermoSmart
  Heated humidification as first intention (HH1st) with ThermoSmart
• Device: Without ThermoSmart
  ThermoSmart is switched off

Study Arms

• Active Comparator: Heated humidification as first intention (HH1st)
  Subjects receive heated humidification as first intention with ThermoSmart
  Intervention: Device: 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.
  Intervention: Device: Without ThermoSmart

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2015): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02423681
• Other Study ID Numbers: CIA-101
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fisher and Paykel Healthcare
• Original Responsible Party: Same as current
• Current Study Sponsor: Fisher and Paykel Healthcare
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fisher and Paykel Healthcare
• Verification Date: February 2017