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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02423681
Other study ID # CIA-101
Secondary ID
Status Completed
Phase N/A
First received April 15, 2015
Last updated February 13, 2017
Start date June 2015
Est. completion date October 2016

Study information

Verified date February 2017
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Lung Function and Sleep Unit, St George's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall cost of equipment (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables 6 months
Primary Number and type of additional interventions The number and type of additional interventions (masks, nasal steroids) and the associated cost 6 months
Primary Duration of appointments Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time) 6 months
Primary Number of unplanned follow-ups number of unplanned follow-ups 6 months
Secondary Adherence to therapy Compliance data from the device 6 months
Secondary Therapy Acceptance Number of withdrawals and drop out from the therapy 6 months
Secondary Apnea Hypopnea Index (AHI) AHI to measure the treatment efficacy 6 months
Secondary Leak Total system leak from the device 6 months
Secondary Side effects and symptoms reported Any side effects and symptoms reported with the therapy 6 months
Secondary Self-reported satisfaction Self-reported satisfaction via treatment questionnaires 6 months
Secondary Patient sleeping environment temperature and humidity The temperature and humidity of the patient's environment as measured by a humidity logger 6 months
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