Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms

Primary outcomes

1. Change In Pittsburgh Sleep Quality Index Scores from Baseline to those at Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine how well participants perceived their sleep quality at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey consists of 9 total items (some items have sub questions i.e. item 4 which has parts A and B). Scores are calculated as per survey instructions. Any scores of 5 or above indicate poor perceived sleep quality.

2. Change In Profile of Mood States (POMS) Scores from Baseline to Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine the perceived mood of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This questionnaire has 65 total items and responses are calculated by scoring question responses on a Likert scale fro 0-4, where 0= not at all and 4= extremely. Total numeric scores are determined for the 6 sub scales represented in the survey (i.e. depression, anger, vigor, confusion, tension, and anger) based on which category the item represents. These sub scale scores are then tallied to determine and overall mood score, where higher scores indicate higher levels of depression, anger, tension, confusion, and fatigue. Being that vigor is a positive indicator for mood, these items are reverse scored before being tallied.

3. Change in State Trait Anxiety Inventory Scores from Baseline to Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine the perceived anxiety levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 20 total items, and responses are scored on a Likert scale of 1-4 where 1=almost never and 4=almost always. Any items that are positive are reverse scored before totaling all 20 items. Higher scores indicate higher levels of perceived anxiety.

4. Change In Perceived Stress Scale Scores at Baseline from Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine the perceived stress levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 10 total items, and responses are scored on a Likert scale from 0-4 where 0=Never and 4=Very often. Any items that are positive are reverse scored before totaling all 10 items. Higher scores indicate higher levels of perceived stress.

5. Change In Flinder's Fatigue Scale Scores from Baseline to Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine the perceived fatigue levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 7 total items, and 6 out of the 7 items are scored on a 5-point Likert scale of 0 (Not at all) to 4 (Extremely). The 7th item asks participants during which times of day they typically experience the most fatigue (out of 7 possible options), each time that indicate is counted as a "1" and all times selected are added to determine a score for that item. All 7 items are then tallied to determine a final score, where higher scores indicate higher levels of perceived fatigue.

6. Change In Productivity Scores from Baseline to Days 17 & 31

   Time frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)

   Self report data used to determine the perceived productivity levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This was determined using 1 item from a Life Satisfaction survey. It was scored using a Likert scale where 1 represented "Very Unproductive" and 4 "Very Productivity". Higher scores indicate higher levels of perceived productivity.

7. EMFIT Sleep Tracker data

   Time frame: This data was collected for the 1-month duration of the study (7 days of baseline, 20 days of intervention, 4 days of washout).

   EMFIT sleep tracker reports served as the objective sleep data for the study. Sleep data was collected during the night while participants slept in their own beds. The EMFIT tracker has a sensor strip that goes underneath the participant's mattress, which is connected to a small senor device that plugs into the wall near the bed, and which connects the the participant's WiFi in order to transmit sleep data. This device was used to measure heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.