Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
BEHAVIORALObstructive Sleep Apnea
Questionnaire about CPAP perceptions
Sponsors
Fisher and Paykel Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild-severe OSA patients * Over 18 * Naive to CPAP * Fluent english
Exclusion criteria
* Comorbidities * Other sleep disorders * Inability to tolerate CPAP * Shift worker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to CPAP Treatment | 14 Days, 60 Days, 90 Days | 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. |
| Reliability of Patient Perception Questionnaire | 14 days, 60 days, 90 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obstructive Sleep Apnea Obstructive Sleep Apnea: Questionnaire about CPAP perceptions | 217 |
| Total | 217 |
Baseline characteristics
| Characteristic | Obstructive Sleep Apnea |
|---|---|
| Age, Continuous | 54.1 Years |
| Race/Ethnicity, Customized Caucasian | 170 Participants |
| Race/Ethnicity, Customized Other | 47 Participants |
| Region of Enrollment United States | 217 participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 217 |
| other Total, other adverse events | 0 / 217 |
| serious Total, serious adverse events | 0 / 217 |
Outcome results
Primary
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.
Time frame: Baseline and 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q1 | .04 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q2 | .14 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q3 | .10 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q5 | .25 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q6 | .01 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q7 | .29 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q8 | .16 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q9 | .12 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q10 | .19 r value |
| Obstructive Sleep Apnea | To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. | Q4 | .13 r value |
Secondary
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.
Time frame: 14 Days, 60 Days, 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obstructive Sleep Apnea | Adherence to CPAP Treatment | 60 Days | 322 Minutes | Standard Deviation 118 |
| Obstructive Sleep Apnea | Adherence to CPAP Treatment | 90 Days | 317 Minutes | Standard Deviation 119 |
| Obstructive Sleep Apnea | Adherence to CPAP Treatment | 14 Days | 335 Minutes | Standard Deviation 118 |
Secondary
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.
Time frame: 14 days, 60 days, 90 days
Population: Due to missing or incomplete data and drop outs, only participants who had completed all 10 questions of the PPQ were included in the analysis for each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obstructive Sleep Apnea | Reliability of Patient Perception Questionnaire | 60 days | 6.35 units on a scale | Standard Deviation 0.92 |
| Obstructive Sleep Apnea | Reliability of Patient Perception Questionnaire | 90 days | 6.06 units on a scale | Standard Deviation 1.14 |
| Obstructive Sleep Apnea | Reliability of Patient Perception Questionnaire | 14 days | 6.43 units on a scale | Standard Deviation 0.99 |