NCT02067000

Brief Summary

Validation of the patient perception questionnaire relating to CPAP use

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

September 12, 2013

Results QC Date

August 10, 2017

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 90 days

Secondary Outcomes (2)

  • Adherence to CPAP Treatment

    14 Days, 60 Days, 90 Days

  • Reliability of Patient Perception Questionnaire

    14 days, 60 days, 90 days

Study Arms (1)

Obstructive Sleep Apnea

Behavioral: Obstructive Sleep Apnea

Interventions

Questionnaire about CPAP perceptions

Obstructive Sleep Apnea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OSA patients

You may qualify if:

  • Mild-severe OSA patients
  • Over 18
  • Naive to CPAP
  • Fluent english

You may not qualify if:

  • Comorbidities
  • Other sleep disorders
  • Inability to tolerate CPAP
  • Shift worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Clinical Research Scientist
Organization
Fisher and Paykel Healthcare

Study Officials

  • Eric Powell

    Clayton Sleep Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

February 20, 2014

Study Start

April 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

July 15, 2020

Results First Posted

July 15, 2020

Record last verified: 2020-07

Locations