ANSI CTA-2052.1-2016 Definitions and Characteristics for Wearable Sleep Monitors.pdf

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1、 ANSI/CTA Standard Definitions and Characteristics for Wearable Sleep Monitors ANSI/CTA/NSF-2052.1 September 2016 NOTICE Consumer Technology Association (CTA) Standards, Bulletins and other technical publications are designed to serve the public interest through eliminating misunderstandings between

2、 manufacturers and purchasers, facilitating interchangeability and improvement of products, and assisting the purchaser in selecting and obtaining with minimum delay the proper product for his particular need. Existence of such Standards, Bulletins and other technical publications shall not in any r

3、espect preclude any member or nonmember of the Consumer Technology Association from manufacturing or selling products not conforming to such Standards, Bulletins or other technical publications, nor shall the existence of such Standards, Bulletins and other technical publications preclude their volu

4、ntary use by those other than Consumer Technology Association members, whether the standard is to be used either domestically or internationally. Standards, Bulletins and other technical publications are adopted by the Consumer Technology Association in accordance with the American National Standard

5、s Institute (ANSI) patent policy. By such action, the Consumer Technology Association does not assume any liability to any patent owner, nor does it assume any obligation whatever to parties adopting the Standard, Bulletin or other technical publication. This document does not purport to address all

6、 safety problems associated with its use or all applicable regulatory requirements. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations before its use. This document is copyrighted by

7、the Consumer Technology Association (CTA) and the National Sleep Foundation (NSF) and may not be reproduced, in whole or part, without written permission. Federal copyright law prohibits unauthorized reproduction of this document by any means. Organizations may obtain permission to reproduce a limit

8、ed number of copies by entering into a license agreement. Requests to reproduce text, data, charts, figures or other material should be made to the Consumer Technology Association (CTA) and the National Sleep Foundation (NSF). (Formulated under the cognizance of the CTA R6.4 Health 2007. 2. Berry RB

9、, Brooks R, Gamaldo CE, Harding SM, Lloyd RM, Marcus CL, Vaughn BV. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. WWW. AASM. ORG. Darien, IL: American Academy of Sleep Medicine, 2015. 3. Orem J, Barnes CD (Eds). Physiology in Sleep.

10、 New York: Elsevier 2012. 4. Sleep Research Society. Basics of Sleep Behavior. Los Angeles, CA: UCLA and Sleep Research Society; 1993. 5. Hirshkowitz M, Sharafkhaneh A. The physiology of sleep. In: Guilleminault C (Ed). Handbook of Clinical Neurophysiology- Clinical Neurophysiology of Sleep Disorder

11、s. Philadelphia: Elsevier, 2005; 3-20. 6. Avidan AY. Normal Sleep in Humans. In: Kryger MH, Avidan AY, Berry RB (Eds). Atlas of Clinical Sleep Medicine (2nd Edition). Philadelphia, PA: Elsevier; 2014, 70-97. 2.2 Compliance Notation As used in this document “shall” and “must” denote mandatory provisi

12、ons of the standard. “Should” denotes a provision that is recommended but not mandatory. “May” denotes a feature whose presence does not preclude compliance, and implementation of which is optional. “Optional” denotes items that may or may not be present in a compliant device. 2.3 Definitions Two ty

13、pes of terms will be defined in this document: (1) Elemental terms and (2) derived terms. Elemental terms are those that are determined directly from self-declaration, visual observation, ongoing phenomena, or biosensors. By contrast, derived terms are calculated directly from elemental terms and re

14、quire no indicators other than those required by the elemental terms used to make the calculation. For the purpose of this document, the follow format will be used for defining each term: Primary Definition: General Meaning of the term used. These are consumer-friendly definitions applicable to norm

15、al healthy sleepers. Indicators: For each elemental term, the types of signs or measures that may be used to determine whether an individual meets criteria are provided (e.g., self-declaration, visual observation, detectable phenomena, and/or biosensor signals). Calculation: For each derived term, t

16、he method or formula used to calculate the parameter is provided. Alternative Definition: Definitions used in sleep research and sleep medicine. 2.4 Symbols and Abbreviations ANS Autonomic Nervous System CTA-2052.1 9 BP Blood Pressure EDA Electrodermal Activity EEG Electroencephalography EMG Electro

17、myogram EOG Electro-oculogram HR Heart Rate NREM Non-Rapid Eye Movement REM Rapid Eye Movement 3. Definitions, Indicators, and Calculations A - General Terms Describing the Temporal Surrounding a Sleep Episode This section defines terms describing a sleep episodes temporal surround. These are genera

18、l terms related to the sleepers intention and the environment, because a person may be in bed without an intention to sleep leads to the distinction between these two elements. The main parameters related to the Time when individual is Attempting To Sleep (TATS) and the Time when the individual is I

19、n Bed (TIB). A.1 (Elemental): TATS Start Time Primary Definition: Time that the individual is in bed and begins attempting to sleep. Indicators: Indicators may include but are not limited to: self-declared intention to sleep (e.g., indicator button on a device), closing of the eyes while an individu

20、al is in bed. Alternative Definition: None. A.2 (Elemental): TATS End Time Primary Definition: Time that the individual is in bed and is no longer attempting to sleep. Indicators: Indicators may include but are not limited to: self-declared intention to remain awake (e.g., indicator button on a devi

21、ce), increased motion/mobility for a certain amount of time, opening of the eyes. Alternative Definition: None. A.3 (Elemental): TIB Start Time Primary Definition: The time that an individual gets into bed. Indicators: Indicators may include but are not limited to: Self-declared status that an indiv

22、idual has gotten into bed, visual observation, sensors indicating an individual is horizontal, and bed or room sensors indicating that a person has gotten into bed. Alternative Definition: In the laboratory this term is actually used to designate TATS Start Time. It is also sometimes called “Lights

23、Out Time”. A.4 (Elemental): TIB End Time Primary Definition: The time that an individual gets out of bed. Indicators: Indicators may include but are not limited to: Self-declared status that an individual has gotten out of bed, visual observation, sensors indicating an individual is not horizontal,

24、and bed or room sensors indicating that a person has gotten out of bed. Alternative Definition: Same as primary definition; however, in the laboratory this term is actually used to designate TATS End Time. It is also sometimes called “Lights On Time”. A.5 (Derived) Total TATS Duration Primary Defini

25、tion: Total time duration that the individual is in bed and is attempting to sleep excluding time in bed not intending to sleep (watching TV, reading a book, etc.). Calculation: The amount of time from TATS Start Time to TATS End Time. Alternative Definition: None. CTA-2052.1 10 A.6 (Derived) Total

26、TIB Duration Primary Definition: The total duration of time that an individual is in bed. Calculation: The total amount of time from TIB Start Time to TIB End Time. Alternative Definition: Same as primary definition; however, in the laboratory this term is actually used to designate Total TATS Durat

27、ion. B. General Terms Describing Basic Features of Wakefulness and Sleep Terminology in this section terminology used to describe events once there is an intention to sleep. Some of the terms in this section have both general and laboratory definitions. Terms such as “sleep” existed long before poly

28、somnographic procedures were applied to investigate the neurophysiology, psychophysiology, and general physiology of sleep. These terms include (but are not limited to): Awake, asleep, and awakening from sleep. Additionally, other sleep measures can be derived from these parameters (e.g., total slee

29、p time and number of awakening). This section defines such terms. It is worth noting that actigraphs, using accelerometers, usually worn on the wrist and resembling a wrist-watch, have long been used in sleep research. Sleep features commonly derived from actigraphic devices include: Total sleep per

30、iod, total sleep time, sleep latency, sleep efficiency (or sleep maintenance), and awakening rate per hour. These actigraphic measures compare favorably with laboratory standards. Each actigraph differs with respect to their precision and accuracy and should be compared to a reference standard to de

31、termine its performance characteristic if it is being used as a clinical or medical device B.1 (Elemental): Awake Primary Definition: Moments when one is not asleep. Usually accompanied by consciousness and/or awareness. Can also be accompanied by purposeful movements. Indicators: Wakefulness may in

32、clude but is not limited to: cognitive awareness and/or consciousness, responsiveness to environmental cues, EEG beta and/or alpha waves, consciousness, sustained movement, eyes open, voluntary eye movements, eye blinks, EMG increases on the chin, heart rate increase, respiration increase, blood pre

33、ssure increase, slow body temperature increase (and will drop again if sleep begins or resumes), increased Electrodermal activity, increased blood flow. Alternative Definition: Wakefulness can be polysomnographically defined as a 30-second epoch in which eyes are open and low-voltage, mixed frequenc

34、y EEG activity is present. If eyes are closed and the subject is not engaged in strenuous mental activity, EEG alpha activity persists for 15 seconds (or more) of the 30-second epoch. B.2 (Elemental): Asleep Primary Definition: A period when one is less responsive to the environment and relatively i

35、mmobile, but it is a rapidly reversible state. It usually includes a lack of alertness and consciousness. Sleep is associated with multiple bodily functions and benefits. Indicators: In healthy individuals, indicators of sleep may include but not limited to: reduced mobility; eyes closure; eyes twit

36、ches; disengagement from environment; lack of response to stimuli (that is rapidly reversible); loss of consciousness; decline in heart rate; increased R-R variability; decline in body temperature; decline in respiration; reduction in alpha EEG waves; increase in EEG theta and delta waves; decline i

37、n oxygen saturation; decline in blood pressure. Alternative Definition: Sleep can be polysomnographically defined as any epoch meeting scoring criteria for N1, N2, N3, or REM sleep. In general, however, an epoch must contain less than 15 seconds of EEG alpha activity. B.3 (Elemental): Awakening from

38、 Sleep Primary Definition: To cease sleeping the sleeper may or may not be aware of this sleep disturbance. Indicators: Same indicators as for term Awake but must follow immediately after sleep was present. CTA-2052.1 11 Alternative Definition: Polysomnograhic criteria for an awakening is the same a

39、s for being awake for more than 15 seconds if it follow immediately after sleep was present. B.4 (Elemental): Brief Awakening Primary Definition: An awakening the sleeper is typically not aware of this sleep disturbance. Indicators: Same indicators as for term Awakening. Alternative Definition: A br

40、ief awakening defined by polysomnographic criteria is called a central nervous system (CNS) arousal. A disruption of sleep that lasts between 3-15 seconds. Arousals from REM sleep require 3-15 seconds of EEG Beta and/or alpha activity and an increase in submentalis EMG. B.5 (Elemental): Brief Moment

41、 of Sleep (Dozing) Primary Definition: A brief transition from wakefulness to sleep (e.g.,3-30 seconds) with a subsequent return to wakefulness. The individual may be unaware of the brief sleep episode. Indicators: Same indicators as for term Asleep but must be contiguous (before and after) with the

42、 presence of wakefulness. Alternative Definition: None. B.6 (Derived): Total sleep period duration (TSPD) Primary Definition: The duration of time from initial sleep onset time to final awakening time. Calculation: Usually reported in hours and minutes or total number of minutes. This measure includ

43、es time awake occurring after the initial sleep onset and before the final awakening. Alternative Definition: The same calculation is used for polysomnographic data. B.7 (Derived): Total sleep time (TST) Primary Definition: The total amount of time spent asleep. Calculation: Sum of all asleep time w

44、ithin a sleep period. Alternative Definition: The same calculation is used for polysomnographic data. B.8 (Derived): Sleep maintenance percentage Primary Definition: The amount of time spent asleep as a percentage of the sleep period. This measure is sometimes called the sleep maintenance index. Cal

45、culation: (TST/TSPD)*100. Alternative Definition: The same calculation is used for polysomnographic data. B.9 (Derived): Total wakefulness duration Primary Definition: The amount of time spent awake during time attempting to sleep. Calculation: The amount of time spent awake from TATS start time unt

46、il TATS end time. Alternative Definition: Polysomnographically, total wakefulness duration from lights out to lights on. B.10 (Derived): Wakefulness duration after initial sleep onset Primary Definition: The amount of time spent awake during a sleep period. Calculation: The amount of time spent awak

47、e from initial sleep onset until final awakening. Alternative Definition: The same calculation is used for polysomnographic data and the resulting metric is called wake after sleep onset (WASO). B.11 (Derived): Number of awakenings Primary Definition: The number of times an individual transitions fr

48、om sleep to wakefulness during the total sleep period. Calculation: Sum of awakenings occurring during a sleep period. Alternative Definition: The same calculation is used for polysomnographic data. CTA-2052.1 12 B.12 (Derived): Number of brief awakenings Primary Definition: The number of brief awak

49、enings from sleep during the total sleep period. Calculation: Sum of brief awakenings during a sleep period. Alternative Definition: The same calculation is used for polysomnographic data. B.13 (Derived): Awakening rate per hour Primary Definition: The number of awakenings per hour in a sleep period. Calculation: (number of awakenings)/TSPD*60). Alternative Definition: The same calculation is used for polysomnographic data. B.14 (Derived): Sleep fragmentation rate Primary Definition: The rate at which sleep is disturbed by awakenings and brief awakenings. Calculation: (number of awaken