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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG047894 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to: 1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy | Experimental | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
|
| Paced Respiration | Experimental | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paced Respiration | Behavioral | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary | Baseline to 12 weeks |
| Change From Baseline in Urgency Incontinence Episodes at 12 Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Huang, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Music Therapy | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy |
| FG001 | Paced Respiration | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Music Therapy | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy |
| BG001 | Paced Respiration |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary. | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 12 weeks |
|
Baseline to 12 weeks.
At each phone and in-person contact, participants were asked about any negative changes in their health.
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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 | Music Therapy | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Music Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold/Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Huang, MD | University of California, San Francisco | 415-514-8697 | alison.huang@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2016 | May 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music Therapy | Behavioral | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
|
Self-reported on voiding diary |
| Baseline to 12 weeks. |
| Change From Baseline in Total Voiding Episodes at 12 Weeks. | Self-reported on voiding diary. | Baseline to 12 weeks |
| Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks | A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome. | Baseline to 12 weeks. |
| Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe. | Baseline to 12 weeks. |
| Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life. | Baseline to 12 weeks |
| Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks. | A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress. | Baseline to 12 weeks |
| Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks. | A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe. | Baseline to 12 weeks |
| Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks. | A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. | Baseline to 12 Weeks |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks. | A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety. | Baseline to 12 Weeks |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks. | A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression. | Baseline to 12 weeks |
| Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks. | A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress. | Baseline to 12 weeks |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks. | An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. | Baseline to 12 weeks |
| Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks. | Resting (neutral) state | Baseline to 12 weeks |
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks. | Change in autonomic control as assessed by high frequency heart rate variability (RSA) | Baseline to 12 weeks |
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks. | High frequency heart rate variability | Baseline to 12 weeks |
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks | high frequency heart rate variability | Baseline to 12 weeks |
| Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks. | PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography . | Baseline to 12 weeks |
| Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks. | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Baseline to 12 weeks |
| Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Baseline to 12 weeks |
| Illness/Medical Reason |
|
| Intolerance/Lack of Improvement |
|
Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Incontinence Frequency | Measure Description: Urge incontinence is a sudden and strong need to urinate. Urinary incontinence is the involuntary leakage of urine. | Mean | Standard Deviation | Episodes per day |
|
| Overactive Bladder Questionnaire | A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome. | Mean | Standard Deviation | score on a scale |
|
| Urgency Severity and Impact Questionnaire | A 13-item measure of the severity and impact of urgency validated specifically in patients with Overactive Bladder (OAB). Possible score range 0-100. Higher the severity score, the more severe. | Mean | Standard Deviation | score on scale |
|
| Urogenital Distress Inventory Short Form (UDI-6) | A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence. Scores range from 0-100. The higher the score, the more distress. | Mean | Standard Deviation | score on scale |
|
| Patient Perception of Bladder Condition (PPBC) | A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale. Score range of 1-6. The higher the score, the more severe. | Mean | Standard Deviation | score on scale |
|
| Spielberger State Trait Anxiety Inventory (STAI), Trait Component | A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. | Mean | Standard Deviation | Score on scale |
|
| Hospital Anxiety and Depression Scale (HADS), Anxiety Subscale | A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials.50 Scores range from 0 to 21, with higher scores indicating greater anxiety. | Mean | Standard Deviation | score on scale |
|
| Center for Epidemiologic Studies Depression Scale (CES-D) | A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression. | Mean | Standard Deviation | Score on Scale |
|
| Perceived Stress Scale (PSS) | A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress. | Mean | Standard Deviation | Score on scale |
|
| Pittsburgh Sleep Quality Index (PSQI) | An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. | Mean | Standard Deviation | Score on scale |
|
| Respiratory Sinus Arrhythmia (RSA) | high frequency heart rate variability | Measure was completed by a subset of participants. | Mean | Standard Deviation | msec^2 |
|
| Pre-ejection Period (PEP) | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Measure Analysis Population Description: Measure was completed by a subset of participants. | Mean | Standard Deviation | msec |
|
|
|
|
| Secondary | Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Urgency Incontinence Episodes at 12 Weeks. | Self-reported on voiding diary | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 12 weeks. |
|
|
|
|
| Secondary | Change From Baseline in Total Voiding Episodes at 12 Weeks. | Self-reported on voiding diary. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks | A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks. |
|
|
|
|
| Secondary | Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks. |
|
|
|
|
| Secondary | Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life. | Although 77 participants randomized to Music Therapy and 74 participants randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks. | A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks. | A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks. | A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks. | A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks. | A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks. | A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress. | Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks. | An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks. | Resting (neutral) state | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec^2 | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks. | Change in autonomic control as assessed by high frequency heart rate variability (RSA) | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec^2 | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks. | High frequency heart rate variability | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec2 | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks | high frequency heart rate variability | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec^2 | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks. | PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography . | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks. | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline to 12 weeks |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 12 |
| 82 |
| EG001 | Paced Respiration | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Paced Respiration | 0 | 79 | 0 | 79 | 10 | 79 |
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |