Trial Outcomes & Findings for Controlling Urgency Through Relaxation Exercises (NCT NCT02202031)

NCT ID: NCT02202031

Last Updated: 2019-07-30

Results Overview

Self-reported on voiding diary.

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2019-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	82	79
Overall Study COMPLETED	77	74
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	1	0
Overall Study Too Busy	1	3
Overall Study Illness/Medical Reason	0	2
Overall Study Intolerance/Lack of Improvement	3	0

Baseline Characteristics

Measure was completed by a subset of participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Music Therapy n=82 Participants 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	Paced Respiration n=79 Participants 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	Total n=161 Participants Total of all reporting groups
Age, Continuous	61.67 years STANDARD_DEVIATION 10.9 • n=82 Participants	60.35 years STANDARD_DEVIATION 11.4 • n=79 Participants	61.02 years STANDARD_DEVIATION 11.1 • n=161 Participants
Sex: Female, Male Female	82 Participants n=82 Participants	79 Participants n=79 Participants	161 Participants n=161 Participants
Sex: Female, Male Male	0 Participants n=82 Participants	0 Participants n=79 Participants	0 Participants n=161 Participants
Race/Ethnicity, Customized Asian/Asian-American	6 Participants n=82 Participants	7 Participants n=79 Participants	13 Participants n=161 Participants
Race/Ethnicity, Customized Latina	6 Participants n=82 Participants	12 Participants n=79 Participants	18 Participants n=161 Participants
Race/Ethnicity, Customized Mixed	7 Participants n=82 Participants	3 Participants n=79 Participants	10 Participants n=161 Participants
Race/Ethnicity, Customized Non-Latina African-American	12 Participants n=82 Participants	12 Participants n=79 Participants	24 Participants n=161 Participants
Race/Ethnicity, Customized Non-Latina White	49 Participants n=82 Participants	40 Participants n=79 Participants	89 Participants n=161 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=82 Participants	5 Participants n=79 Participants	7 Participants n=161 Participants
Region of Enrollment United States	82 participants n=82 Participants	79 participants n=79 Participants	161 participants n=161 Participants
Incontinence Frequency Urgency Incontinence	1.19 Episodes per day STANDARD_DEVIATION 1.6 • n=82 Participants	1.37 Episodes per day STANDARD_DEVIATION 2.0 • n=79 Participants	1.28 Episodes per day STANDARD_DEVIATION 1.8 • n=161 Participants
Incontinence Frequency Moderate Sensation of Urgency Incontinence or Void	6.77 Episodes per day STANDARD_DEVIATION 3.8 • n=82 Participants	7.10 Episodes per day STANDARD_DEVIATION 2.9 • n=79 Participants	6.93 Episodes per day STANDARD_DEVIATION 3.4 • n=161 Participants
Incontinence Frequency Severe Sensation of Urgency Incontinence or Void	2.42 Episodes per day STANDARD_DEVIATION 2.3 • n=82 Participants	3.01 Episodes per day STANDARD_DEVIATION 2.6 • n=79 Participants	2.71 Episodes per day STANDARD_DEVIATION 2.4 • n=161 Participants
Incontinence Frequency Daytime voiding	9.70 Episodes per day STANDARD_DEVIATION 3.8 • n=82 Participants	9.81 Episodes per day STANDARD_DEVIATION 2.8 • n=79 Participants	9.76 Episodes per day STANDARD_DEVIATION 3.3 • n=161 Participants
Incontinence Frequency Nighttime voiding	1.42 Episodes per day STANDARD_DEVIATION 1.0 • n=82 Participants	1.25 Episodes per day STANDARD_DEVIATION 1.0 • n=79 Participants	1.34 Episodes per day STANDARD_DEVIATION 1.0 • n=161 Participants
Incontinence Frequency Total voiding	11.12 Episodes per day STANDARD_DEVIATION 3.9 • n=82 Participants	11.06 Episodes per day STANDARD_DEVIATION 2.9 • n=79 Participants	11.09 Episodes per day STANDARD_DEVIATION 3.4 • n=161 Participants
Overactive Bladder Questionnaire	27.59 score on a scale STANDARD_DEVIATION 11.4 • n=82 Participants	29.12 score on a scale STANDARD_DEVIATION 9.9 • n=79 Participants	28.35 score on a scale STANDARD_DEVIATION 10.7 • n=161 Participants
Urgency Severity and Impact Questionnaire Severity Subscale	58.51 score on scale STANDARD_DEVIATION 11.7 • n=82 Participants	58.45 score on scale STANDARD_DEVIATION 14.5 • n=79 Participants	58.48 score on scale STANDARD_DEVIATION 13.1 • n=161 Participants
Urgency Severity and Impact Questionnaire Health-Related Quality of Life Subscale	21.94 score on scale STANDARD_DEVIATION 15.4 • n=82 Participants	24.57 score on scale STANDARD_DEVIATION 19.4 • n=79 Participants	23.23 score on scale STANDARD_DEVIATION 17.5 • n=161 Participants
Urogenital Distress Inventory Short Form (UDI-6)	45.19 score on scale STANDARD_DEVIATION 17.3 • n=82 Participants	45.57 score on scale STANDARD_DEVIATION 19.6 • n=79 Participants	45.38 score on scale STANDARD_DEVIATION 18.4 • n=161 Participants
Patient Perception of Bladder Condition (PPBC)	2.65 score on scale STANDARD_DEVIATION 1.0 • n=82 Participants	2.61 score on scale STANDARD_DEVIATION 1.1 • n=79 Participants	2.63 score on scale STANDARD_DEVIATION 1.0 • n=161 Participants
Spielberger State Trait Anxiety Inventory (STAI), Trait Component	36.82 Score on scale STANDARD_DEVIATION 10.2 • n=82 Participants	38.49 Score on scale STANDARD_DEVIATION 10.5 • n=79 Participants	37.64 Score on scale STANDARD_DEVIATION 10.3 • n=161 Participants
Hospital Anxiety and Depression Scale (HADS), Anxiety Subscale	6.22 score on scale STANDARD_DEVIATION 3.8 • n=82 Participants	6.72 score on scale STANDARD_DEVIATION 4.0 • n=79 Participants	6.47 score on scale STANDARD_DEVIATION 3.9 • n=161 Participants
Center for Epidemiologic Studies Depression Scale (CES-D)	10.17 Score on Scale STANDARD_DEVIATION 8.5 • n=82 Participants	11.87 Score on Scale STANDARD_DEVIATION 10.1 • n=79 Participants	11.01 Score on Scale STANDARD_DEVIATION 9.3 • n=161 Participants
Perceived Stress Scale (PSS)	13.40 Score on scale STANDARD_DEVIATION 6.6 • n=82 Participants	14.41 Score on scale STANDARD_DEVIATION 7.0 • n=79 Participants	13.89 Score on scale STANDARD_DEVIATION 6.8 • n=161 Participants
Pittsburgh Sleep Quality Index (PSQI)	7.11 Score on scale STANDARD_DEVIATION 3.2 • n=82 Participants	7.42 Score on scale STANDARD_DEVIATION 3.8 • n=79 Participants	7.26 Score on scale STANDARD_DEVIATION 3.5 • n=161 Participants
Respiratory Sinus Arrhythmia (RSA) Change from rest to dot task	0.35 msec^2 STANDARD_DEVIATION 0.6 • n=22 Participants • Measure was completed by a subset of participants.	-0.11 msec^2 STANDARD_DEVIATION 0.6 • n=30 Participants • Measure was completed by a subset of participants.	0.08 msec^2 STANDARD_DEVIATION 0.6 • n=52 Participants • Measure was completed by a subset of participants.
Respiratory Sinus Arrhythmia (RSA) Change from rest to maze task	-0.10 msec^2 STANDARD_DEVIATION 0.6 • n=22 Participants • Measure was completed by a subset of participants.	-0.56 msec^2 STANDARD_DEVIATION 1.0 • n=30 Participants • Measure was completed by a subset of participants.	-0.37 msec^2 STANDARD_DEVIATION 0.9 • n=52 Participants • Measure was completed by a subset of participants.
Respiratory Sinus Arrhythmia (RSA) Resting (neutral) state	4.75 msec^2 STANDARD_DEVIATION 1.2 • n=22 Participants • Measure was completed by a subset of participants.	5.69 msec^2 STANDARD_DEVIATION 1.6 • n=30 Participants • Measure was completed by a subset of participants.	5.29 msec^2 STANDARD_DEVIATION 1.5 • n=52 Participants • Measure was completed by a subset of participants.
Pre-ejection Period (PEP) Change from rest to dot task	-3.84 msec STANDARD_DEVIATION 9.7 • n=22 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	-0.02 msec STANDARD_DEVIATION 6.1 • n=29 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	-1.67 msec STANDARD_DEVIATION 8.0 • n=51 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.
Pre-ejection Period (PEP) Change from rest to maze task	-4.21 msec STANDARD_DEVIATION 11.6 • n=22 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	-0.81 msec STANDARD_DEVIATION 8.7 • n=29 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	-2.27 msec STANDARD_DEVIATION 10.1 • n=51 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.
Pre-ejection Period (PEP) Resting (neutral) state	123.07 msec STANDARD_DEVIATION 11.5 • n=22 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	117.11 msec STANDARD_DEVIATION 14.8 • n=29 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.	119.68 msec STANDARD_DEVIATION 13.7 • n=51 Participants • Measure Analysis Population Description: Measure was completed by a subset of participants.

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Self-reported on voiding diary.

Outcome measures

Outcome measures
Measure	Music Therapy n=73 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.	-1.06 episodes Interval -1.74 to -0.37	-0.86 episodes Interval -1.5 to -0.13

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

Self-reported on voiding diary

Outcome measures

Outcome measures
Measure	Music Therapy n=73 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.	-0.85 episodes Interval -1.24 to -0.46	-0.94 episodes Interval -1.32 to -0.55

SECONDARY outcome

Timeframe: Baseline to 12 weeks.

Self-reported on voiding diary

Outcome measures

Outcome measures
Measure	Music Therapy n=73 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.	-0.63 episodes Interval -0.85 to -0.4	-0.55 episodes Interval -0.77 to -0.33

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Self-reported on voiding diary.

Outcome measures

Outcome measures
Measure	Music Therapy n=73 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Total Voiding Episodes at 12 Weeks.	-1.04 episodes Interval -1.49 to -0.6	-1.08 episodes Interval -1.52 to -0.63

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks	-15.45 score on a scale Interval -18.03 to -12.87	-14.29 score on a scale Interval -16.91 to -11.68

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.	-15.56 score on a scale Interval -18.81 to -12.32	-13.85 score on a scale Interval -17.13 to -10.56

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Music Therapy n=73 Participants 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	Paced Respiration n=71 Participants 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
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.	-12.35 score on a scale Interval -15.3 to -9.39	-10.18 score on a scale Interval -13.17 to -7.18

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.	-15.35 score on a scale Interval -19.07 to -11.64	-17.11 score on a scale Interval -20.88 to -13.35

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.	-0.74 score on a scale Interval -0.95 to -0.53	-0.88 score on a scale Interval -1.09 to -0.66

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.	-2.42 score on a scale Interval -3.82 to -1.02	-2.85 score on a scale Interval -4.27 to -1.43

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.	-0.71 score on a scale Interval -1.23 to -0.19	-1.38 score on a scale Interval -1.9 to -0.86

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.	-1.97 score on a scale Interval -3.25 to -0.69	-3.01 score on a scale Interval -4.31 to -1.72

SECONDARY outcome

Timeframe: Baseline to 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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.	-1.12 score on a scale Interval -2.23 to -0.02	-2.83 score on a scale Interval -3.95 to -1.71

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Music Therapy n=76 Participants 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	Paced Respiration n=74 Participants 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
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.	-1.22 score on a scale Interval -1.74 to -0.7	-1.14 score on a scale Interval -1.67 to -0.62

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Resting (neutral) state

Outcome measures

Outcome measures
Measure	Music Therapy n=19 Participants 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	Paced Respiration n=25 Participants 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
Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.	-0.40 msec^2 Interval -1.13 to 0.32	-0.27 msec^2 Interval -1.09 to 0.55

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Change in autonomic control as assessed by high frequency heart rate variability (RSA)

Outcome measures

Outcome measures
Measure	Music Therapy n=19 Participants 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	Paced Respiration n=25 Participants 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
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.	-0.40 msec^2 Interval -1.13 to 0.32	-0.27 msec^2 Interval -1.09 to 0.55

SECONDARY outcome

Timeframe: Baseline to 12 weeks

High frequency heart rate variability

Outcome measures

Outcome measures
Measure	Music Therapy n=19 Participants 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	Paced Respiration n=25 Participants 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
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.	0.58 msec2 Interval -0.28 to 1.43	0.33 msec2 Interval -0.66 to 1.32

SECONDARY outcome

Timeframe: Baseline to 12 weeks

high frequency heart rate variability

Outcome measures

Outcome measures
Measure	Music Therapy n=19 Participants 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	Paced Respiration n=25 Participants 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
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks	0.69 msec^2 Interval -0.09 to 1.47	0.26 msec^2 Interval -0.61 to 1.13

SECONDARY outcome

Timeframe: Baseline to 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 .

Outcome measures

Outcome measures
Measure	Music Therapy n=18 Participants 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	Paced Respiration n=24 Participants 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
Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.	-3.41 msec Interval -21.94 to 15.12	0.34 msec Interval -20.19 to 20.86

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

Outcome measures

Outcome measures
Measure	Music Therapy n=18 Participants 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	Paced Respiration n=24 Participants 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
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.	1.28 msec Interval -5.12 to 7.69	1.87 msec Interval -4.85 to 8.6

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

Outcome measures

Outcome measures
Measure	Music Therapy n=18 Participants 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	Paced Respiration n=24 Participants 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
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks	-4.79 msec Interval -14.07 to 4.49	-6.35 msec Interval -16.56 to 3.87

Adverse Events

Music Therapy

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Paced Respiration

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Music Therapy n=82 participants at risk 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	Paced Respiration n=79 participants at risk 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
Respiratory, thoracic and mediastinal disorders Cold/Flu	14.6% 12/82 • Number of events 13 • Baseline to 12 weeks. At each phone and in-person contact, participants were asked about any negative changes in their health.	12.7% 10/79 • Number of events 11 • Baseline to 12 weeks. At each phone and in-person contact, participants were asked about any negative changes in their health.

Additional Information

Alison Huang, MD

University of California, San Francisco

Phone: 415-514-8697

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place