Equivalence of Activity Recordings and Derived Sleep Statistics

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1 Actiwatch-64 Equivalence of Activity Recordings and Derived Sleep Statistics Actiwatch-64,Actiwatch 2 and Actiwatch Spectrum Mary Coughlin RN, MS, NNP, Global Clinical Services Managers, Children s Medical Ventures Actiwatch 2 Abstract The Actiwatch-64, Actiwatch 2 and Actiwatch Spectrum wrist-worn activity loggers produce substantially equivalent results, for recorded activity and calculated sleep statistics, when subjected to similar in-lab and real-life movement regimens. In-lab frequency response measurements to uniform sinusoidal motion for time synchronized devices demonstrated excellent reproducibility for activity measures collected from the new and previous models. Matched pairs testing with adult subjects wearing a pair of devices over a 24-hour period were used as an additional basis of comparison of activity and calculated sleep statistics. No differences for any of the sleep statistics examined were detected between Actiwatch models. Actiwatch Spectrum PHILIPS RESPIRONICS

2 Introduction The Actiwatch-64 device is used in research and clinical settings to detect and record wrist motion of human subjects during wake and sleep periods.the fundamental scientific principle of the Actiwatch is that a miniature piezo-electric transducer produces a voltage in response to a change in motion.the voltage is amplified, digitized and then recorded on board the device in non-volatile memory. Later, the recorded data are transferred to a personal computer and can be subsequently analyzed to quantify activity during intervals characteristic of both wake and sleep. Like Actiwatch-64, the Actiwatch 2 and Actiwatch Spectrum devices utilize a piezo-electric sensor as the activity-sensing element. Unlike the Actiwatch-64 sensor, the sensor in the Actiwatch 2 and Actiwatch Spectrum devices is fully enclosed by a miniature ceramic package directly applied to the electronic circuit board.the incorporation of this accelerometer package into the Actiwatch 2 and Actiwatch Spectrum models has resulted in designs with enhanced durability, repeatability and linearity over previously available options. We have compared activity values obtained from the devices under strictly controlled test conditions.additionally, Actiwatch-64 was paired with each of the other Actiwatch devices to determine the equivalence of activity recordings while recording from actual subjects. Because sleep and wake statistics are derived from the recorded physical activity values, a comparative analysis of commonly used sleep statistics between the Actiwatch-64 and the Actwatch 2 and Actiwatch Spectrum models to establish concordance is also included in this report.

3 Methods Test FixtureTrials To display equivalence of activity data from the Actiwatch devices, activity data were recorded from eight of each Actiwatch models (Actiwatch-64,Actiwatch 2, and Actiwatch Spectrum). Individual devices were selected at random to be tested. Each was configured with an epoch length of 15 seconds using Actiware 5.5 application software.a validated, calibrated, NIST-traceable mechanical wave motion fixture swept each device through a distance of +/- 5 cm at different frequencies ranging from 0.5 Hz to 4 Hz.The various movement frequencies simulate different intensities of human physical activity.after each test, data were transferred from each device to a personal computer using the Actiware software application via the ActiReader and communication docks. No additional signal conditioning or processing was used after data transfer. Paired DeviceTrials To illustrate the substantial equivalence of activity data and sleep statistics received from the three models of Actiwatch under typical usage conditions, time-synchronized, matched pairs of devices (one Actiwatch-64 along with either an Actiwatch 2 or Actiwatch Spectrum) were worn by 12 research subjects for up to 14 days. Device pairs were configured identically and attached together firmly to ensure that consistency of the orientation for the pairs was maintained. Sleep statistics were derived from 20 individual rest intervals using the default analytical settings for the Actiware software. The statistics included: SleepTime: The time in minutes scored as Sleep by the Actiware Software. WakeTime: Total minutes scored as Wake by the Actiware Software. Sleep Efficiency: The Sleep Efficiency percentage for the rest interval. Sleep Efficiency is calculated by dividing sleep time by the number of minutes in the rest interval. Wake After Sleep Onset (WASO): The number of minutes of wake detected by the Actiware Software after the subject initially fell asleep. Sleep Onset Latency: The sleep onset latency in minutes.the number of minutes that were determined to have passed between the start of the rest interval and the first epoch of scored sleep.this is determined by the Actiware sleep onset detection algorithm Actiwatch Actiwatch / 0 I Freq (Hz) Freq (Hz) Actiwatch Spectrum Figure 1. Response of Actiwatch-64, Actiwatch 2 and Actiwatch Spectrum to acceleration of increasing frequency on a test fixture.the superior concordance below 1.5 Hz indicates that sleep scoring outcomes should be highly similar / "T Freq (Hz)

4 Results Test FixtureTrials Figure 1 shows the average activity counts against test fixture sweep frequency for eight of each model of Actiwatch tested.all devices recorded a minimum of variation in activity counts through the range of frequencies tested. No significant differences in activity values recorded at any frequency were noted between the new devices and the Actiwatch-64 under these controlled conditions. Achieving superior concordance for measures below 1.5 Hz is of primary importance to establish equivalent performance between devices and models for sleep statistics. Movement at this frequency results in recorded activity counts that are similar to the sleep/wake determination threshold in Actiware software. Movement at frequencies above 1.5 Hz results in a number of activity counts higher than the wake determination threshold.the sleep scoring algorithm utilizes a default wake threshold value of 40 activity counts and ranges from 20 to 80 for the purposes of scoring wake in published polysomnographic comparisons. Paired DeviceTrials The activity values recorded by pairs of Actiwatch-64 and Actiwatch 2 and Actiwatch Spectrum were highly correlated.the relative equivalence of the activity records from each model are easily seen in sample scatter plots. Correlation coefficients are shown in Figure 2. Comparisons of means for sleep statistics derived from the matched pair activity records are shown in Figure 3. No significant differences between calculated means were observed for any of the sleep statistics. Mean values for Sleep time, Sleep Efficiency and Sleep Onset Latency were virtually identical between the Actiwatch-64 and the Actiwatch 2 and Actiwatch Spectrum models (p > 0.97). Mean values for Wake time and WASO were indistinguishable (p > 0.69) Actiwatch-64 vs Actiwatch 2 ' ' :4111=EM. y = x 300 R = ;r13:: '' ':. :..I!I Actiwatch Actiwatch-G4 vs Actiwatch Spectrum ' ' ' y = x R2 = o.. -.IZ t7... ' , Actiwatch Actiwatch 2 vs Actiwatch Spectrum Figure 2. Scatter plots for activity values received from matched pairs of Actiwatch-64, Actiwatch 2, and Actiwatch Spectrum devices worn simultaneously on the same wrist for 24 hours i..., Fa' y =1.1011x R2 = Actiwatch

5 Conclusions Test fixture trials as well as 24-hour paired device trials on human subjects indicate that the performance of the piezo-electric accelerometers utilized for the Actiwatch models tested are highly consistent between models of the device and result in equivalent activity records and sleep statistics. Actiwatch-64, Actiwatch 2 and Actiwatch Spectrum provide highly reliable, reproducible and significantly equivalent activity records when subjected to similar movement either mechanically or in matched paired testing on research subjects. Because sleep/wake statistics are the primary outcome measure from an Actiwatch device, the consistency of recorded activity at the low end of the activity scale (< counts) is of utmost importance. This report establishes that the current and new devices produce substantially equivalent values for movements within the low range of the activity scale and that the Actiwatch devices may be used interchangeably for the purposes of calculating sleep statistics when used with the algorithms embedded within the Actiware software program.the Actiwatch 2 and Actiwatch Spectrum accelerometers provide equivalent results to the Actiwatch-64 with significant improvements in reproducibility and ruggedness. Sleep Time (mins) AW-fi be i New AW Sleep Efficiency (%) AW-64 Onset Latency (mins) maw-64 New AW New AW Figure 3. Comparison of the mean values of the sleep statistics generated from Actiwatch-64 and the Actiwatch 2 and Actiwatch Spectrum.

6 Philips Healthcare is part of Royal Philips Electronics How to reach us Fax: Asia Europe, Middle East,Africa Latin America Philips Respironics Empire Avenue, Building B-3 Bend, OR Customer Service (toll free) Respironics Europe, Middle East,Africa Respironics Asia Pacific North America (toll free, US only) For more information on the Actiwatch family of products, visit: Respironics,Actiwatch and Actiware are trademarks of Respironics, Inc. and its affiliates. PHILIPS 2009 Koninklijke Philips Electronics N.V. All rights are reserved. Philips Healthcare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Geyer SB 5/23/08 MCI

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