Night Shift Product Training

  1. Using the Device
    1. Functionality
    2. Settings
    3. User Instructions
  2. Reports
    1. Daily Report
    2. Monthly report
    3. One-Year report
    4. Compliance Monitoring With All reports
  3. Software
    1. Key functions
    2. Night Shift Portal software
    3. Night Shift Mobile App
  4. Clinical Considerations
    1. Patient Selection
    2. Site Selection - Neck vs. Chest
    3. Factors that Influence Night Shift Compliance
    4. Position Therapy vs. CPAP and Oral Appliance Therapies
    5. Benefit of Combination Therapy
    6. Supine Sleep in Heart Failure Patients
    7. Supine Sleep and CPAP Effectiveness
    8. Supine Sleep and Neurodegeneration
  5. Data Privacy, Security, and Data Transfer
    1. Data Storage
    2. Regulatory Status
    3. Compliance Monitoring
  6. Distributor Considerations
    1. Warranty
    2. Maintenance
    3. Repair and Returns
  1. Using the Device
    1. Functionality
      1. Delivers supine avoidance vibrotactile feedback
        1. Initiates feedback at an extremely low vibrational setting every other second for six vibrations (12 seconds)
        2. If the user doesn’t change positions, intensity increases for six vibrations (12 seconds)
        3. Pattern repeats across seven levels of vibration intensity, and then randomly vibrates until a position change occurs
      2. When initially turned on, the device vibrates to indicate the number of nights it can deliver therapy before needing to be recharged (i.e., 3, 2 or 1 night)
      3. Supine avoidance feedback
        1. Default to delay for 15-minutes after it’s turned on
        2. Optionally set to begin feedback after a 30-minute delay
        3. Delay is skipped when the on/off button is held down for > 5 secs until the device vibrates
          1. 1) Used to demonstrate vibration patterns to the patient or for troubleshooting
        4. Every five-seconds with LED is blinking amber and does not stop with a position change
          1. 1) Indicates device needs to be recharged
      4. Recharges in 2 hours
      5. LED blink patterns indicate:
        1. Steady green first 5 minutes after turning on; dimmed steady green after 5 minutes
        2. Amber blinking every second with vibration once every 5 seconds indicates needs to be recharged
        3. Plugged in – steady green indicates charging
        4. Plugged in – no LEDs indicate charging is complete
      6. Recharges in 2 hours
        1. First 15 minutes after the device is turned off (e.g., in the morning)
        2. When plugged into a wall charger or computer
    2. Settings
      1. Chest Belt setting
        1. Does not report sleep efficiency/arousals and wake after sleep onset
        2. Reported snoring magnitude is greater vs. when worn around the neck
      2. No Vibration setting
        1. Enables device to be used to passively monitor position, snoring, etc. for up to 7-nights without recharge
      3. Trial setting
        1. Device does not vibrate on Night 1
        2. Supine avoidance feedback begins on Night 2 and continues every night thereafter
        3. Resets to begin Night 1 vibration pattern when “Clear Study History” is selected (i.e., removes old data in preparation for a new patient)
          1. 1) When the device is used for patient trials when the diagnostic night is followed by a therapy night.
      4. Maximum recording time – 10 or 12 hours
        1. Feature automatically turns device off to save battery power and reduce the likelihood of compromised compliance data because the user forgets to turn the device off in the morning
      5. Off Button Behavior –
        1. Long hold extends the length of time the off button must be held down to activate
        2. Intended for users with finger dexterity issues who find short duration responses difficult or for users who turn the device off while sleeping
      6. Bluetooth – on or off
        1. Saves battery power for users who don’t want to use the mobile app
      7. Settings can be selected using either portal software or mobile app
    3. User Instructions
      1. Night Shifts will be shipped with English language user instructions unless ordered using part number NS27-1005.LE followed by the country designation e.g., FRE=France, ITA=Italy, DUT=Netherlands, GER=Germany
      2. User instructions for a second language can be ordered at no cost using part number NS27-8101.LE followed by the country designation
      3. User instructions can be downloaded from the Night Shift portal for supported country languages
  2. Reports
    1. Daily report
      1. Includes colorful graphical hypnograms for each of the most recent 7-days that include:
        1. Hours used
        2. Supine time and % supine
          1. 1) Based on recording time minus the first 15-minutes
        3. % time snoring > 50 dB, overall supine and non-supine based on
          1. 1) Based on recording time minus the first 15-minutes
          2. 2) Excludes sound generated during vibrational feedback periods
        4. Sleep time, sleep efficiency, wake after sleep onset, arousals/hour (neck position only)
        5. Number of supine attempts
          1. 1) Timing marked with red line on position hypnogram
        6. Feedback response time – typical time (seconds), minimum and maximum, time reflected in the width of red line on hypnogram
      2. When “Trial Mode” setting is selected, the original baseline study with “no vibration” will be presented as the eighth day
      3. The daily report generated by the mobile app for no vibration and with feedback is a slightly different from the portal format
    2. Monthly report
      1. Monitor compliance by selecting the most recent 30-days, 90-days or calendar month to obtain
        1. Hours used
        2. Supine time and % supine
          1. 1) Based on recording time minus the first 15-minutes
        3. % time snoring > 50 dB, overall supine and non-supine based on
          1. 1) Based on recording time minus the first 15-minutes
          2. 2) Excludes sound generated during vibrational feedback periods
        4. Sleep time, sleep efficiency, wake after sleep onset, arousals/hour (neck position only)
        5. Number of supine attempts
          1. 1) Timing marked with red line on position hypnogram
        6. Feedback response time – typical time (seconds), minimum and maximum, time reflected in the width of red line on hypnogram
    3. One-Year Report
      1. Averages values in the monthly report for the most recent 12 calendar months, or the calendar months that are available
    4. Compliance Monitoring With All reports
      1. Single document with all three reports is combined in the following order
        1. Detailed reports for the most recent 8 nights
        2. Up to three x 30-day reports
        3. A one-year report
      2. Detailed guidance for interpretation of all three reports can be accessed here
  3. Software
    1. Key functions
      1. Select the language for software use
      2. Generate reports
        1. See Section II
      3. Managing the device
        1. Select settings – see Section I.B.
      4. Registering the Device – see Section IV.A. Warranty
        1. This registration page can be used to register each device
        2. Alternatively, registration can be done using the portal software
      5. Functions can be applied using:
        1. Night Shift portal with a web browser
        2. Night Shift Therapy mobile app
    2. Night Shift Portal software
      1. Supports the following web browsers: Chrome, Firefox, Microsoft Edge, Safari
      2. Requires installation by completing these steps:
        1. Download at Night Shift portal software
        2. Once installed, launch the portal software
      3. After installation, launch again by selecting the Night Shift icon (which automatically appears on the user’s desktop after 1st launch) for convenient continuous access to the Night Shift portal
      4. Alternatively, the portal software can be opened from launch web page
      5. The portal allows any of the settings listed in Section I.B. to be selected. Some settings are hidden, use instructions here (section C) to access all settings.
    3. Night Shift Mobile App
      1. The Night Shift Therapy app is available in the respective stores for both Apple and Android mobile devices.
      2. When installing the app, the following settings must be allowed:
        1. Use Bluetooth – allow
        2. Location – allow
        3. Access to media – allow
        4. For android additionally include Nearby Device – allow
      3. The app allows any of the settings listed in Section I.B. to be selected. Some settings are hidden, use instructions here (section E) to access all settings.
      4. The user can generate and review any of the Night Shift report(s) from their phone or tablet.
      5. The app allows the reports to be emailed to a primary and alternative email address, when entered.
  4. Clinical Considerations
    1. Patient Selection
      1. Older patients are more likely to have severe position dependent OSA
        1. Geriatric patients unable to tolerate CPAP should be considered for positional therapy
      2. The AHI reduction as a result of supine avoidance can be estimated using the ratio overall AHI divided by the non-supine AHI
        1. Incorporates the combination of supine severity and time spent supine in the decision
        2. An overall / NS AHI ratio of 1.35 approximates a 35% reduction in overall AHI when supine sleep is eliminated
      3. The Overall/Non-supine criteria had the highest sensitivity, specificity, diagnostic odds ratio and positive likelihood ratios, and lowest negative likelihood ratios compared to the Cartwright (i.e., supine / non-supine AHI > 2.0), APOC, and Mador criteria.
      4. Estimate the in-home overall/non-supine AHI ratio
        1. Place the Night Shift in trial mode to record the first night with “no vibration”.
        2. Use this spreadsheet to enter the combination of a) diagnostic supine and non-supine AHI with b) the recording and % supine time during one night with the Night Shift in “no vibration” mode (i.e., first night in trial mode).
        3. If the overall AHI / non-supine AHI > 1.4 then a robust treatment effect is expected.
    2. Site Selection - Neck vs. Chest
        3. Efficacy
      1. The skin contains sensory receptors that transform the amplitude and frequency of vibration pulses into an electrical signal interpreted by the brain.
      2. The back of the neck has the greatest number of sensory receptors in the human body. Feedback to this location results in:
        1. Shorter duration feedback is needed to trigger a position change.
        2. Patients with a high arousal threshold being overly sensitive to positional feedback.
      3. The chest and waist areas have far fewer sensory receptors than the neck and greater distributions of adipose tissue (fat) that muffles the feedback. Thus
        1. The intensity and duration of the vibrotactile feedback needed to elicit a position change is significantly greater, and the resulting noise can awaken the bed partner
      4. Detection of the true supine position is more accurate when measured from the neck
        1. The agreement between video-detected and Night Shift detected neck position was 0.93 vs. 0.78 for video-detected and Night Shift detected chest position.
      5. When the Night Shift is worn on the chest:
        1. Reported snoring amplitude will be greater because of the proximity of the microphone.
        2. Sleep-wake and arousals will not be reported because chest wall movement as a result of breathing is interpreted as awake.
      6. Differences between neck vs. chest reports, with and without feedback, can be accessed here
        Comfort
      1. The silicone neck strap can be worn loosely while remaining in place, but it can cause the neck to sweat when the ambient temperature is hot.
      2. Women tend to prefer the chest belt, in part because they’re used to wearing tight fitting clothing around their mid-section and not tight collars.
      3. If the chest belt extension is required to accommodate the patient’s size, it’s more likely they do not have positional sleep apnea.
    3. Factors that Influence Night Shift Compliance
      1. Patients are more likely to be compliant when positional therapy:
        1. Keeps them off their back, they feel like they slept better or feel better during the day, find it more comfortable than other therapies, and/or their physician told them to use it regularly.
      2. Patients who discontinue position therapy find it ineffective when:
        1. They’re diagnosed with positional OSA by in-lab PSG but sleep supine significantly less in the home, so the overall AHI reduction/symptomatic benefit is limited.
        2. They’re non-responsive to the vibrotactile feedback because they’re taking sedatives, have chronic sleep deprivation, and/or motor limitations.
    4. Position Therapy vs. CPAP and Oral Appliance Therapies
      1. Meta analysis of comparative effectiveness of positional therapy, oral appliance therapy, and CPAP showed:
        1. Position therapy significantly improved the arousal index compared to oral appliance therapy
        2. Position therapy had lower risk of device complications compared to oral appliance therapy and CPAP.
      2. Night Shift was equivalent to CPAP in a prospective crossover trial
        1. Equivalent in Epworth Sleepiness Scale reductions
        2. No differences in sleep architecture, overall daily usage, quality of life or psychomotor vigilance task measures.
        3. Fifty percent of patients preferred CPAP and 48% preferred Night Shift
      3. Meta analysis of oral appliance therapy vs. positional therapy found
        1. Changes in total and supine AHI, sleep efficiency and functional outcomes of sleep questionnaire were equivalent
        2. Only oral appliance therapy reduced the non-supine AHI
      4. Night Shift increased stage N3 sleep time compared to oral appliance therapy
    5. Benefit of Combination Therapy
      1. Position therapy plus oral appliance therapy reduced the overall AHI reduction approximately two times greater than either therapy alone.
      2. Uvulopalatopharyngoplasty outcomes are more successful in patients with positional OSA.
    6. Supine Sleep in Heart Failure Patients
      1. Greater central sleep apnea and Cheyne Stokes respiration severity in heart failure patients
      2. More severe Cheyne-Stokes respiration in patients with cardiovascular disease
      3. Increased central sleep apnea as cardiac dysfunction progresses
      4. Increased number of angina episodes
    7. Supine Sleep and CPAP Effectiveness
      1. CPAP titration in the lateral position improved outcomes in those with higher BMI, higher neck and waist circumference and spent more time with SpO2 < 90%.
      2. Lateral sleep increases CPAP efficacy
      3. The residual apnea-hypopnea index and arousal index were lower in the non-supine positions
    8. Supine Sleep and Neurodegeneration
      1. Increased supine sleep is associated with
        1. Increased risk of a neurodegenerative disorder
        2. increased disease duration and motor impairment in Parkinson’s patients
  5. Data Privacy, Security, and Data Transfer
    1. Data Storage
      1. All data used to generate a Night Shift report is stored internally on the device in a file called “Study.acq” which:
        1. Identifies the saved data based on the device serial number
        2. Does not contain patient health information if patient does not enter name/birth date when generating their report
        3. Is small in size and easy to transfer via email (i.e., 64kB)
        4. Contains the username and/or birth date if entered by the patient when generating their report.
      2. A copy of the Study.acq is saved on the Night Shift server each time a report is generated.
      3. Contents of the Study.acq is erased when the software feature “Clear Study History‘ is selected.
    2. Regulatory Status
      1. Patient privacy is maintained, with respect to utilization of the device, by allowing users the option to generate reports without their personal health identifier (i.e., name and/or birth date).
      2. Patients can then choose to share their Night Shift report(s) with their healthcare provider with or without their personal health information.
      3. Privacy notifications are provided in both the Portal and the Mobile App as to
        1. The information collected, how it is used when it is shared, etc.
      4. This approach enables the Night Shift portal to be compliant with:
        1. Health Insurance Portability and Availability Act (HIPAA)
        2. Health Information Technology for Economic and Clinical Health Act (HITECH)
        3. The European Union (EU) General Data Protection Regulation (GDPR)
        4. EU-US with UK Extension and Swiss-US Data Privacy Framework (DPF)
      5. Night Shift data are hosted on a server in the Netherlands.
    3. Compliance Monitoring
      1. Access to compliance information requires the user to generate a report using either portal software or the mobile app
      2. Options for compliance monitoring include:
        1. Manual email transfer of report(s) generated by the user with portal software
        2. Transfer of all reports to a third party email address entered into the Mobile app
        3. Automatic transfer of user data for selected compliance metrics via the NS Integration Web Service with data access restricted by
          1. 1) Bearer Tokens assigned by ABM to each account
          2. 2) Data extracted from device serial numbers sold/assigned to each account
      3. Specifications for NS Integration Web Service can be accessed here.
  6. Distributor Considerations
    1. Warranty
      1. Neck strap – 6-months
        1. Common failure – release of magnetic clasp by pulling causes silicone end to fail
      2. Chest strap – 6-months
        1. Typical useful life >12 months
      3. Haptic motors – 12-months
        1. Typical useful life 3+ years
        2. Most common cause of failure – patient is consistently slow to response to feedback
      4. Battery – 12-months
        1. Typical useful life 3+ years
        2. Identified when recharged device won’t support 3 nights with typical feedback time
        3. Failure rates increase if device sits for > 3 months without charging
      5. PCB electronic components within enclosure – 24-months
      6. Warranty period – begins when
        1. Device is registered to a patient
        2. Arrives at distributor if device is not registered
      7. Detailed warranty information can be accessed here
    2. Maintenance
      1. Supporting devices and software
        1. Many resources for support of devices and software can be accessed on the Night Shift User Support Page
      2. Managing inventory
        1. Recharge for a minimum of 30-minutes and at least once every 3-months
        2. Update the firmware and reset to the local time zone
        3. Ensure the patient instructions are in local language
        4. Adjust the settings (e.g., set to chest belt, etc.)
      3. Prepare device for reuse with a new patient
        1. Use the Factory Reset button from Quick Test, then adjust settings as needed
        2. Enclosure – wipe thoroughly with alcohol
        3. Neck or chest belt – replace or wash with warm water and mild detergent
    3. Repair and Returns
      1. Repairs and Return Merchandise Authorization (RMA)
        1. Distributors are responsible for replacing batteries and haptic motors
        2. Download, unzip and install the Quick Test files.
        3. Perform a “Quick Test” in an attempt to diagnose/repair the device before you request an RMA to be issued.
        4. ABM will not issue RMAs for devices in use longer than 3-years.
        5. Replacement devices only shipped in conjunction with new orders.
      2. Technical Support Inquiries
        1. Submit requests to NightShift@Advanced-sleep.com
        2. Required information includes:
          1. 1) Serial number
          2. 2) Date of purchase by the End User
          3. 3) Detailed description of the problem
          4. 4) Quick Test results or note that the device cannot be recognized
          5. 5) The Study.acq file, accessed by following these steps:
            1. a) Connect the Night Shift to the computer
            2. b) Open a File Explorer window
            3. c) Under Devices and drives, locate and click on the device named “ABM”
            4. d) Select the Study.acq file and attach it to your email support request