Obstructive Sleep ApneaNCT02067000
Patient Perception Questionnaire Validation
An observational study of Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
Validation of the patient perception questionnaire relating to CPAP use 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?
- Obstructive Sleep Apnea
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: OSA patients
Who may be able to join
- Mild-severe OSA patients
- Over 18
- Naive to CPAP
- Fluent english
Who cannot join
- Comorbidities
- Other sleep disorders
- Inability to tolerate CPAP
- Shift worker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Patient Perception Questionnaire
Validation of the patient perception questionnaire relating to CPAP use
Read the detailed description
This research is designed to validate a questionnaire which aims to predict patient adherence to CPAP, therefore enabling the healthcare provider to better target initiatives to improve adherence.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Obstructive Sleep Apnea
- 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.
Obstructive Sleep ApneaBehavioural
Questionnaire about CPAP perceptions
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Not described Receives: Behavioral: Obstructive Sleep Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days.
The PPQ is a custom questionnaire including 10 questions evaluating perceptions of OSA and CPAP treatment. Each question is derived from models of psychology such as self-regulatory ability and social support. Q1 ranges from 0-10, with 10 indicating OSA negatively impacts life. Q2 ranges from 0-10, with 10 indicating belief that OSA will last forever. Q3 ranges from 0-10, with 10 indicating that CPAP is extremely necessary to control OSA. Q4 ranges from 1-10, with 10 indicating no intention of using CPAP at all. Q5 ranges from 1-10, with 10 indicating presence of a highly supportive spouse. Q6 ranges from 1-10, with 10 indicating benefit of CPAP is well understood. Q7 ranges from 0-10, with 10 indicating extreme concern about using CPAP. Q8 ranges from 1-10, with 10 indicating high confidence with using CPAP. Q9 ranges from 1-10, with 10 indicating high perception that CPAP will help treat OSA. Q10 ranges from 1-10, with 10 indicating spouses negative attitude toward CPAP use.
Measured: Baseline and 90 days
Secondary outcomes (2)
Adherence to CPAP Treatment
An assessment of participants adherence to CPAP treatment after 90 days. Data was extracted from CPAP device compliance reports.Adherence was defined as use for 4 hours or more per night for 70% of nights in each report period at 14, 60 and 90 days.
Measured: 14 Days, 60 Days, 90 Days
Reliability of Patient Perception Questionnaire
To determine the stability/consistency (reliability) of the PPQ at three time points during the first 90 days of CPAP treatment usage. At each of these time points, the exact same PPQ as described in the Primary Outcome Measure was re-administered to determine whether the scores remained consistent over time. The answer responses described in the Primary Outcome measure also remain the same. Total PPQ was calculated as an average of the 10 questions. Total score ranges from 0-10 with higher scores indicating a worse outcome.
Measured: 14 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Powell, Principal investigator, Clayton Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067000
- Sponsor's protocol ID
- CIA-44
- Status last verified
- Jul 2020
- First submitted
- 12 Sep 2013
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Patient Perception Questionnaire
- ClinicalTrials.gov ID
- NCT02067000
- Acronym / sponsor ID
- CIA-44
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation of the patient perception questionnaire relating to CPAP use
Detailed description
This research is designed to validate a questionnaire which aims to predict patient adherence to CPAP, therefore enabling the healthcare provider to better target initiatives to improve adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | Behavioral: Obstructive Sleep Apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OSA patients
Key inclusion criteria (4 listed)
- Mild-severe OSA patients
- Over 18
- Naive to CPAP
- Fluent english
Key exclusion criteria (4 listed)
- Comorbidities
- Other sleep disorders
- Inability to tolerate CPAP
- Shift worker
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 |
|---|---|---|
| Obstructive Sleep ApneaQuestionnaire about CPAP perceptions | Behavioural | Obstructive Sleep Apnea |
Primary outcome
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days.
Time frame: Baseline and 90 days
The PPQ is a custom questionnaire including 10 questions evaluating perceptions of OSA and CPAP treatment. Each question is derived from models of psychology such as self-regulatory ability and social support. Q1 ranges from 0-10, with 10 indicating OSA negatively impacts life. Q2 ranges from 0-10, with 10 indicating belief that OSA will last forever. Q3 ranges from 0-10, with 10 indicating that CPAP is extremely necessary to control OSA. Q4 ranges from 1-10, with 10 indicating no intention of using CPAP at all. Q5 ranges from 1-10, with 10 indicating presence of a highly supportive spouse. Q6 ranges from 1-10, with 10 indicating benefit of CPAP is well understood. Q7 ranges from 0-10, with 10 indicating extreme concern about using CPAP. Q8 ranges from 1-10, with 10 indicating high confidence with using CPAP. Q9 ranges from 1-10, with 10 indicating high perception that CPAP will help treat OSA. Q10 ranges from 1-10, with 10 indicating spouses negative attitude toward CPAP use.
2 secondary outcomes
Adherence to CPAP Treatment
Time frame: 14 Days, 60 Days, 90 Days
Reliability of Patient Perception Questionnaire
Time frame: 14 days, 60 days, 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eric Powell principal investigator
Clayton Sleep Institute
1 site 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 1 site 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 4 inclusion and 4 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 Jul 2020. 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 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?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. (time frame: Baseline and 90 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 15 Jul 2020.