Obstructive Sleep ApneaNCT02309749
CAP Pilot Study for Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in United States.
Trial summary
This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CAP
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Dec 2014
- Phase
- Observational
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sleep laboratory, DME supplier
Who may be able to join
- 21 to 75 years of age
- Diagnosed with OSA (AHI >5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
- Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
- Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
- Access to a cellphone
Who cannot join
- Contraindicated for CPAP therapy
- Medically unstable condition/diagnosis that is not yet under control
- Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
- Periodic Leg MOvement Arousal Index greater than 15/hr
- Home titration of longer than 5 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sleep Therapy Research Center
San Antonio, Texas
Clayton Sleep Institute
St Louis, Missouri
About this study
This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CAP
- 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.
CAPOther
| Study group | Role | What they receive |
|---|---|---|
| Naive cohort | Not described Receives: Other: CAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of delivery of SMS messages to participant
Cross check recieved messages logged in a diary by the participant to those sent by CAP
Measured: 30 days
Secondary outcomes (1)
Participant CPAP Adherence
Assess the adherence of participants to CPAP therapy while enrolled in CAP
Measured: 30 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionDec 2014
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309749
- Sponsor's protocol ID
- FPH-AD13-01
- Status last verified
- Dec 2014
- First submitted
- 2 Apr 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAP Pilot Study for Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02309749
- Acronym / sponsor ID
- FPH-AD13-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Dec 2014 (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.
This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naive cohort | – | Other: CAP |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sleep laboratory, DME supplier
Key inclusion criteria (5 listed)
- 21 to 75 years of age
- Diagnosed with OSA (AHI >5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
- Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
- Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
- Access to a cellphone
Key exclusion criteria (5 listed)
- Contraindicated for CPAP therapy
- Medically unstable condition/diagnosis that is not yet under control
- Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
- Periodic Leg MOvement Arousal Index greater than 15/hr
- Home titration of longer than 5 days
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 |
|---|---|---|
| CAP | Other | Naive cohort |
Primary outcome
Accuracy of delivery of SMS messages to participant
Time frame: 30 days
Cross check recieved messages logged in a diary by the participant to those sent by CAP
1 secondary outcome
Participant CPAP Adherence
Time frame: 30 nights
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 8 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in United States.
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 5 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Accuracy of delivery of SMS messages to participant (time frame: 30 days). 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 8 Dec 2014.