Contactless and minimal-contact monitoring of quality of life parameters for assessment and intervention

• US 9,223,935 B2
• Filed: 09/23/2009
• Issued: 12/29/2015
• Est. Priority Date: 09/24/2008
• Status: Active Grant

• Current Assignee: ResMed Sensor Technologies Limited (ResMed Incorporated)
• Original Assignee: ResMed Sensor Technologies Limited (ResMed Incorporated)
• Inventors: Heneghan, Conor, Fox, Niall, Zaffaroni, Alberto, De Chazal, Philip, Hanley, Conor
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US13/120,640
• Publication Number:
  US 20110178377A1
• Time in Patent Office: 2,288 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An apparatus, system, and method for the measurement, aggregation and analysis of data collected using non-contact or minimally-contacting sensors provides quality of life parameters for individual subjects, particularly in the context of a controlled trial of interventions on human subjects (e.g., a clinical trial of a drug, or an evaluation of a consumer item such as a fragrance). In particular, non-contact or minimal-contact measurement of quality-of-life parameters such as sleep, stress, relaxation, drowsiness, temperature and emotional state of humans may be evaluated, together with automated sampling, storage, and transmission to a remote data analysis center. One component of the system is that the objective data is measured with as little disruption as possible to the normal behavior of the subject. The system can also support behavioral and pharmaceutical interventions aimed at improving quality of life.

Claims

1. A system for monitoring the quality of life of humans, comprising:

at least one physiological sensor configured to wirelessly receive a signal reflected from a subject indicative of measured data, derive measured data from the reflected signal, and to wirelessly transmit the measured data to a handheld portable device;

the handheld portable device comprising;

an interface for collecting subjective data from the subject, wherein the subjective data comprises sleep quality data and other quality of life data; and

a transmitter configured to transmit the measured data transmitted by the at least one physiological sensor and the subjective data collected from the interface to a remote data monitoring center for calculating one or more of a sleep quality of life duration, fragmentation, efficiency, and latency index value on the basis of the measured data and subjective data transmitted to the remote data monitoring center.

2. The system of claim 1, further comprising at least one environmental sensor configured to measure data indicative of environmental parameters.

3. The system of claim 2, wherein the at least physiological or environmental sensor is arranged at least 50 cm from the subject being monitored to provide an open space therebetween.

4. The system of claim 2, wherein the at least one physiological or environmental sensor is not directly mechanically coupled to the subject.

5. The system of claim 1 wherein the measured data pertains to sleep quality.

6. The system of claim 1 wherein the measured data comprises an objective measurement of sleep combined with a subjective assessment of sleep.

7. The system of claim 1 wherein the measured data is an objective measurement of sleep.

8. The system of claim 1, wherein the portable handheld device further comprises a receiver configured to receive, from the remote data monitoring center, a recommendation provided to the subject, the recommendation being based on the calculated quality of life index value.

9. The system of claim 8, wherein the remote data monitoring center is further configured to:

receive the measured data and subjective data transmitted from the handheld portable device;

calculate the quality of life index value and generate the recommendation to be provided to the subject, based on the calculated quality of life index value; and

transmit the recommendation to the handheld portable device.

10. The system of claim 1, wherein the handheld device further comprises:

a processor that performs initial processing of the measured data and the subjective data; and

wherein the transmitter transmits the initially processed measured data and subjective data to the remote data monitoring center for archiving and analysis.

11. The system of claim 10, the system further comprising:

a receiver to receive a recommendation from the remote data monitoring center based on the initially processed measured data and subjective data; and

an output to provide the recommendation to the subject.

12. A method for monitoring the quality of life of humans, comprising:

receiving, at a handheld portable device, objective data measured from at least one non-contact or minimal contact physiological or environmental sensor;

collecting, via an interface of the portable handheld device, subjective quality of life data from a subject;

transmitting, via the handheld portable device, the objective data and the subjective quality of life data to a remote data monitoring center to facilitate calculation of a quality of life index as a function of at least the measured objective data and the subjective quality of life data, the quality of life index including one or more of a sleep duration index value, a sleep latency index value, or a sleep fragmentation index value; and

receiving, at the handheld portable device, from the data monitoring center a recommendation provided to the subject, the recommendation being based on a calculated quality of life index, wherein the calculated quality of life index includes one or more of a sleep duration index value, a sleep latency index value, or a sleep fragmentation index value.

13. The method of claim 12, wherein the objective data pertains to sleep.

14. The method of claim 12, wherein the subjective quality of life data pertains to sleep.

15. The method of claim 12, wherein measured objective data is collected by the at least one non-contact or minimal contact physiological or environmental sensor that is arranged more than 50 cm from the monitored subject.

16. The method of claim 12, wherein the objective data is collected with no direct mechanical coupling between the at least one non-contact or minimal contact physiological or environmental sensor and the subject.

17. The method of claim 12, wherein the recommendation pertains to a future behavior of the subject, wherein the method further comprises:

receiving at least one additional objective data or collecting at least one additional subjective quality of life data; and

comparing current values of the data to past values of the data.

18. The method of claim 12, wherein the recommendation pertains to a potential change in a pharmaceutical dosing.

19. The method of claim 12, wherein the subjective quality of life data further comprises sleep quality data.

20. The method of claim 12, wherein the method further comprises performing, at the handheld device, initial processing of the objective data and the subjective quality of life data;

and the step of transmitting further includes transmitting the initially processed objective data and subjective quality of life data to the data monitoring center for archiving and further processing.

21. The method of claim 20, wherein the method further comprises providing, via the handheld device, the recommendation to the subject and wherein the received recommendation from the data monitoring center is based on further processed objective data and subjective quality of life data.

22. A method for assessing a quality of life index, the method comprising:

obtaining, at a handheld portable device, at least one objective measurement of physiological or environmental data, wherein the objective measurement is obtained with non-contact or minimal contact with a monitored subject;

receiving, at the handheld portable device, at least one subjective response from the monitored subject about their quality of life;

calculating a quality of life index as a function of the objective measurement and the subjective response the quality of life index including one or more index values for sleep duration, fragmentation, and latency;

querying a database using the quality of life index; and

providing a recommendation to the monitored subject, by way of the handheld portable device, the recommendation being provided in response to querying the database with the quality of life index.

23. The method of claim 22, wherein the subjective response further comprises sleep quality data.

24. The method of claim 22, wherein the at least one objective measurement is a physiological or environmental parameter related to a quality of life assessment of the monitored subject.

25. The method of claim 24, wherein the physiological or environmental parameter is collected by sensing elements arranged more than 50 cm from the monitored subject.

26. The method of claim 24, wherein the physiological or environmental parameter is collected with no direct mechanical coupling between sensing elements and the monitored subject.

27. The method of claim 22, wherein the at least one objective measurement pertains to sleep.

28. The method of claim 22, wherein the subjective response pertains to sleep.

29. The method of claim 22, wherein the recommendation pertains to a future behavior of the monitored subject.

30. The method of claim 22, further comprising:

obtaining at least one additional objective measurement; and

comparing a current value to a past value thereof.

31. The method of claim 22, wherein the recommendation pertains to pharmaceutical dosing.

32. The method of claim 22, wherein at least one subjective response is received from the monitored subject on an interface of the handheld portable device.

33. The method of claim 22, further comprising the steps of:

transmitting, by the handheld portable device, the objective measurement or subjective response to a remote data monitoring center for analysis.

34. The method of claim 33, further comprising the steps of:

receiving, at the handheld portable device, the recommendation for the monitored subject; and

displaying, at the handheld portable device, the recommendation to the monitored subject.

35. A method for assessing a quality of life index, the method comprising:

receiving transmitted objective quality of life data obtained by way of at least one sensor and subjective quality of life data from a monitored subject;

electronically generating, using a portable handheld device, a numerical metric which represents a quality of life index, as a function of the received objective and subjective quality of life data the metric including one or more of a sleep duration, fragmentation, or latency; and

electronically generating a recommendation for the monitored subject in response to querying the database with the numerical metric.

36. The method of claim 35, further comprising the step of transmitting the recommendation to the monitored subject.