Obstructive Sleep ApneaNCT02423681
A Comparison of CPAP With and Without Humidification: A Pilot Study
A study testing ThermoSmart and Without ThermoSmart in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ThermoSmart and Without ThermoSmart
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lung Function and Sleep Unit, St George's Hospital
London
About this study
Official title: Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ThermoSmart, Without ThermoSmart
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoSmartDevice
Heated humidification as first intention (HH1st) with ThermoSmart
Without ThermoSmartDevice
ThermoSmart is switched off
| Study group | Role | What they receive |
|---|---|---|
| Heated humidification as first intention (HH1st) | Active comparator | Subjects receive heated humidification as first intention with ThermoSmart Receives: Device: ThermoSmart |
| Non-heated humidification | Placebo comparator | 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. Receives: Device: Without ThermoSmart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cost of equipment
(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
Measured: 6 months
Number and type of additional interventions
The number and type of additional interventions (masks, nasal steroids) and the associated cost
Measured: 6 months
Duration of appointments
Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)
Measured: 6 months
Number of unplanned follow-ups
number of unplanned follow-ups
Measured: 6 months
Secondary outcomes (7)
Adherence to therapy
Compliance data from the device
Measured: 6 months
Therapy Acceptance
Number of withdrawals and drop out from the therapy
Measured: 6 months
Apnea Hypopnea Index (AHI)
AHI to measure the treatment efficacy
Measured: 6 months
Leak
Total system leak from the device
Measured: 6 months
Side effects and symptoms reported
Any side effects and symptoms reported with the therapy
Measured: 6 months
Self-reported satisfaction
Self-reported satisfaction via treatment questionnaires
Measured: 6 months
Patient sleeping environment temperature and humidity
The temperature and humidity of the patient's environment as measured by a humidity logger
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Parsons, Chief Clinical Physiologist, Principal investigator, Lung Function and Sleep Unit, St George's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423681
- Sponsor's protocol ID
- CIA-101
- Status last verified
- Feb 2017
- First submitted
- 15 Apr 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
- ClinicalTrials.gov ID
- NCT02423681
- Acronym / sponsor ID
- CIA-101
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated humidification as first intention (HH1st) | Active comparator | Device: ThermoSmartSubjects receive heated humidification as first intention with ThermoSmart |
| Non-heated humidification | Placebo comparator | Device: Without ThermoSmartSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermoSmartHeated humidification as first intention (HH1st) with ThermoSmart | Device | Heated humidification as first intention (HH1st) |
| Without ThermoSmartThermoSmart is switched off | Device | Non-heated humidification |
Primary outcome
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
7 secondary outcomes
Adherence to therapy
Time frame: 6 months
Therapy Acceptance
Time frame: 6 months
Apnea Hypopnea Index (AHI)
Time frame: 6 months
Leak
Time frame: 6 months
Side effects and symptoms reported
Time frame: 6 months
Self-reported satisfaction
Time frame: 6 months
Patient sleeping environment temperature and humidity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
Related trials for Obstructive Sleep Apnea
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Parsons, Chief Clinical Physiologist principal investigator
Lung Function and Sleep Unit, St George's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoSmart and Without ThermoSmart in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cost of equipment (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.