Sleep Disordered Breathing
Conditions
Brief summary
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive Airway Pressure therapy. A total of approximately 60 naïve participants will be recruited.
Detailed description
This is a randomized prospective trial designed to obtain subjective and objective feedback in a home use environment with participants using a Philips Respironics System One Positive Airway Pressure device. Participants will be randomly assigned to one of three methods of therapy introduction and monitoring: 1. Group 1: The first group, the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the Positive Airway Pressure device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant. Therapy information is available continuously to site staff personnel in the standard care arm. 2. Group 2: The second group will receive the site's therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. Participants in this group will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously as well. 3. Group 3: The third group will not receive the site's therapy initiation standard of care but will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, and their Philips Respironics mask. and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously as well.
Interventions
OTHERStandard of Care
In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant but will continuously be available to site staff personnel.
DEVICEDreamMapper Application
The DreamMapper application condition will receive the site's therapy initiation standard of care and will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously.
DEVICEDreamMapper Application with Therapist Assist
The DreamMapper with Therapist Assist will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, their Philips Respironics mask and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-75 * Diagnosis of Obstructive Sleep Apnea (OSA) with an Apnea Hypopnea Index (AHI) of at least 15 events/hour of sleep and a Central Apnea Index (CAI) ≤ 5 events /hour or ≤ 50% of the AHI. * Newly diagnosed and Continuous Positive Airway Pressure (CPAP) Naïve. * Currently owns and uses apps on an Android or iPhone smart phone. * Willing to undergo an attended in lab Polysomnography (PSG) * Willing and able to provide informed consent. * Speaks and reads English as their primary language.
Exclusion criteria
* Presence of poorly managed or unstable major medical or psychiatric conditions that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease with daytime hypercapnia, neuromuscular disease, psychiatric disease, cancer, or chronic renal failure. * Participants who are unwilling to try Positive Airway Pressure (PAP) therapy. * Participants currently prescribed oxygen therapy (as needed, nocturnal, or continuous). * Participants with previously diagnosed respiratory failure or respiratory insufficiency. * Recent surgery of the upper airway, noise, sinus, or eyes. * Participant is prescribed a BiPAP device * Commercial Drivers * Shift workers * Participants with untreated periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15). * Participants with untreated known diagnosis of Insomnia (score of 15-21(moderate severity) per Insomnia Severity Index (ISI) ) * Known diagnosis of bipolar disorder * Participant with unstable anti- depressant medication (not stable for 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire | 90 days | Participants will complete the Attitudes Toward Use Questionnaire (0 to 10 scale) to determine user preference of the New Philips Respironics Positive Airway Pressure Application. The higher the value the higher participant confidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Outcomes - Epworth Sleepiness Scale | 90 days | Treatment outcomes will be assess by the Epworth Sleepiness Scale. The Epworth Sleepiness is 8 question survey asking questions about likelihood to fall asleep, each questions is answered on a 0 to 3 scale, 0-no chance, 3-high chance, the higher the score the higher likelihood of daytime sleepiness. The scale is 0-24, 0-no chance to fall asleep. |
| Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) | 90 days | Treatment outcomes will be assess by the Functional Outcomes of Sleep Questionnaire. The FOSQ is a specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. It asks sets of questions for activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (4-no difficulty to 1-extreme difficulty 0-I do not do it for other reasons). 10 questions are asked with the lowest score of 0 and the highest of score of 40. The lower the score the more difficulty it is to complete tasks. |
| Site Economic Savings Assessed by Number of Phone Calls. | 90 days | Site economics savings will be collected and analyzed by reviewing the number of phone calls per arm. Exact numeric amounts of savings are not available but number of calls is. |
| Adherence | 90 days | Adherence will be measured among the three groups to determine which participants used their Positive Airway Pressure device most throughout the trial: DreamMapper compared to site standard of care compared to using DreamMapper and Therapist Assist. |
| Mask Refits | 90 days | Number of patient visits requiring mask refits will be measured and recorded. The exact number of mask refits will be provided. |
| Overall Economic Cost Saving | 90 days | Analysis will be done on the overall economic cost savings from Therapist Assist and DreamMapper |
| Patient Interactions | 90 days | Site and patient interactions will be assessed after 90 days by reviewing the exact number of unscheduled visits in each arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care All participants that were enrolled into the Standard of Care. | 21 |
| DreamMapper Application All participants that were enrolled into the DreamMapper Application. | 21 |
| DreamMapper Application With Therapist Assist All participants that were enrolled into the DreamMapper Application With Therapist Assist. | 20 |
| Total | 62 |
Baseline characteristics
| Characteristic | Standard of Care | DreamMapper Application | DreamMapper Application With Therapist Assist | Total |
|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 11.4 | 46.9 years STANDARD_DEVIATION 11.1 | 47.3 years STANDARD_DEVIATION 10 | 47.0 years STANDARD_DEVIATION 10.7 |
| Body Mass Index (BMI) | 37.8 kg/m^2 STANDARD_DEVIATION 8.5 | 36.4 kg/m^2 STANDARD_DEVIATION 6.6 | 33.7 kg/m^2 STANDARD_DEVIATION 5.1 | 36.0 kg/m^2 STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 21 Participants | 21 Participants | 20 Participants | 62 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 9 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 7 / 21 | 4 / 21 | 4 / 20 |
| serious Total, serious adverse events | 1 / 21 | 0 / 21 | 0 / 20 |
Outcome results
Primary
User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire
Participants will complete the Attitudes Toward Use Questionnaire (0 to 10 scale) to determine user preference of the New Philips Respironics Positive Airway Pressure Application. The higher the value the higher participant confidence.
Time frame: 90 days
Population: All participants completed the study but not all participants completed the questionnaire for day 90. 6 standard of care participants did not complete the survey, 3 dreammapper and 1 dreammapper application with therapy assist did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire | 7.5 units on a scale | Standard Deviation 3.6 |
| DreamMapper Application | User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire | 7.9 units on a scale | Standard Deviation 2.6 |
| DreamMapper Application With Therapist Assist | User Preference of the New Philips Respironics Positive Airway Pressure Application as Measured by the Attitudes Toward Use Questionnaire | 8.8 units on a scale | Standard Deviation 1.5 |
Secondary
Adherence
Adherence will be measured among the three groups to determine which participants used their Positive Airway Pressure device most throughout the trial: DreamMapper compared to site standard of care compared to using DreamMapper and Therapist Assist.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Adherence | 4.6 days per week | Standard Deviation 2.4 |
| DreamMapper Application | Adherence | 4.8 days per week | Standard Deviation 1.7 |
| DreamMapper Application With Therapist Assist | Adherence | 4.0 days per week | Standard Deviation 2.5 |
Secondary
Mask Refits
Number of patient visits requiring mask refits will be measured and recorded. The exact number of mask refits will be provided.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Mask Refits | 2 number of refits |
| DreamMapper Application | Mask Refits | 2 number of refits |
| DreamMapper Application With Therapist Assist | Mask Refits | 3 number of refits |
Secondary
Overall Economic Cost Saving
Analysis will be done on the overall economic cost savings from Therapist Assist and DreamMapper
Time frame: 90 days
Population: Unable to be analyzed based upon site confidential information.
Secondary
Patient Interactions
Site and patient interactions will be assessed after 90 days by reviewing the exact number of unscheduled visits in each arm.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Patient Interactions | 2 number of unscheduled visits |
| DreamMapper Application | Patient Interactions | 3 number of unscheduled visits |
| DreamMapper Application With Therapist Assist | Patient Interactions | 4 number of unscheduled visits |
Secondary
Site Economic Savings Assessed by Number of Phone Calls.
Site economics savings will be collected and analyzed by reviewing the number of phone calls per arm. Exact numeric amounts of savings are not available but number of calls is.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Site Economic Savings Assessed by Number of Phone Calls. | 6 number of phone calls |
| DreamMapper Application | Site Economic Savings Assessed by Number of Phone Calls. | 7 number of phone calls |
| DreamMapper Application With Therapist Assist | Site Economic Savings Assessed by Number of Phone Calls. | 9 number of phone calls |
Secondary
Treatment Outcomes - Epworth Sleepiness Scale
Treatment outcomes will be assess by the Epworth Sleepiness Scale. The Epworth Sleepiness is 8 question survey asking questions about likelihood to fall asleep, each questions is answered on a 0 to 3 scale, 0-no chance, 3-high chance, the higher the score the higher likelihood of daytime sleepiness. The scale is 0-24, 0-no chance to fall asleep.
Time frame: 90 days
Population: All participants completed the study but not all participants completed the questionnaire for day 90. 5 standard of care participants did not complete the survey, 2 dreammapper and 1 dreammapper application with therapy assist did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Treatment Outcomes - Epworth Sleepiness Scale | 6.4 units on a scale | Standard Deviation 4 |
| DreamMapper Application | Treatment Outcomes - Epworth Sleepiness Scale | 7.9 units on a scale | Standard Deviation 6.1 |
| DreamMapper Application With Therapist Assist | Treatment Outcomes - Epworth Sleepiness Scale | 7.7 units on a scale | Standard Deviation 4.8 |
Secondary
Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ)
Treatment outcomes will be assess by the Functional Outcomes of Sleep Questionnaire. The FOSQ is a specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. It asks sets of questions for activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (4-no difficulty to 1-extreme difficulty 0-I do not do it for other reasons). 10 questions are asked with the lowest score of 0 and the highest of score of 40. The lower the score the more difficulty it is to complete tasks.
Time frame: 90 days
Population: All participants completed the study but not all participants completed the questionnaire for day 90. 5 standard of care participants did not complete the survey, 2 dreammapper and 1 dreammapper application with therapy assist did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) | 15.9 units on a scale | Standard Deviation 4.4 |
| DreamMapper Application | Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) | 16.0 units on a scale | Standard Deviation 4 |
| DreamMapper Application With Therapist Assist | Treatment Outcomes - Functional Outcomes of Sleep Questionnaire (FOSQ) | 17.6 units on a scale | Standard Deviation 2 |