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| ID | Type | Description | Link |
|---|---|---|---|
| R43HL162131 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Minnesota HealthSolutions | INDUSTRY |
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The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Comorbid OSA | Experimental | Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based pulmonary rehabilitation (PR) system | Behavioral | Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Use the Devices at Home | The number of participants who were able to utilize the devices at home. | 2 Weeks |
| Usability of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome. | 2 Weeks |
| Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Benzo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Comorbid OSA | Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Comorbid OSA | Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches called patients regularly to celebrate progress, assist with any issues, and set new goals. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Use the Devices at Home | The number of participants who were able to utilize the devices at home. | Posted | Count of Participants | Participants | 2 Weeks |
|
Adverse events were collected from the time of informed consent through study completion, approximately 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Comorbid OSA | Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches called patients regularly to celebrate progress, assist with any issues, and set new goals. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Benzo, M.D. | Mayo Clinic | 480-301-8244 | benzo.roberto@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2024 | Sep 30, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Pilot study
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|
| 2 Weeks |
| Perceived Benefit of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit. | 2 Weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Primary | Usability of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome. | Posted | Mean | Full Range | score on a scale | 2 Weeks |
|
|
|
| Primary | Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome. | Posted | Mean | Full Range | score on a scale | 2 Weeks |
|
|
|
| Secondary | Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence. | Posted | Count of Participants | Participants | 2 Weeks |
|
|
|
| Secondary | Perceived Benefit of Proposed System in Patients With OSA and Obesity | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit. | Posted | Count of Participants | Participants | 2 Weeks |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |