Method and apparatus for maintaining and monitoring sleep quality during therapeutic treatments

• US 20050217674A1
• Filed: 04/08/2005
• Published: 10/06/2005
• Est. Priority Date: 10/09/2002
• Status: Active Grant

• Current Assignee: David Burton, Eugene Zilberg
• Original Assignee: Compumedics Limited
• Inventors: Burton, David, Zilberg, Eugene
• Granted Patent: US 8,069,852 B2
• Time in Patent Office: Days
• US Class Current: 128/204.230
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/62 Posture

Abstract

The present invention monitors and interprets physiological signals and spontaneous breathing events to detect the onset of arousal. Once the onset of arousal is determined, the present invention determines adjustments that are needed in the operation of a therapeutic device to avoid or minimize arousals. In one embodiment, the present invention includes one or more sensors which detect a patient'"'"'s physiological parameters, a controller which monitors and determines the onset of arousal based on the physiological variables received from the sensor, and a therapeutic treatment device which is controlled by the controller. The sensor can be a combination of one or more devices which are able to monitor a physiological parameter that is used by the present invention to determine the onset of arousal or the onset of a sleep disorder. The sensors can be integrated into one unit or may operate independent of the others.

Claims

1. A method of providing a therapeutic treatment to a patient, the method comprising:

setting a treatment level;

monitoring a physiological parameter that is an indicator of arousal;

determining if the monitored physiological parameter indicates onset of arousal; and

adjusting the treatment level to avoid arousal.

2. The method of claim 1, and further comprising the step of determining if an arousal is caused by upper airway resistance (UAR) or by the treatment level.

3. The method of claim 1, wherein the step of adjusting includes varying treatment levels until a treatment level is determined which does not cause arousal.

4. The method of claim 3, and further comprising the step of storing the treatment level which does not cause arousal.

5. The method of claim 1, wherein the step of monitoring includes monitoring of cortical or sub-cortical activity.

6. The method of claim 5, wherein the step of determining includes detecting a shift to alpha or theta EEG activity from a slower background frequency.

7. The method of claim 1, wherein the step of determining includes detecting a drop in the pulse transit time (PTT).

8. The method of claim 1, and further comprising computing an index value from a plurality of monitored parameters and utilizing the index value to predict onset of arousal.

9. The method of claim 1, wherein the step of determining includes comparing a patient airflow waveform with a plurality of templates which depict onset of arousal.

10. The method of claim 1, and further comprising the additional step of providing a table correlating a combination of physiological events to an optimum adjustment of the treatment level which minimizes arousal.

11. The method of claim 10, wherein the step of determining includes detecting whether an event is associated with central apnea or obstructive apnea.

12. The method of claim 1, wherein the step of determining includes utilizing patient specific data to determine thresholds for arousal.

13. The method of claim 1, wherein the step of determining includes comparing cortical and subcortical activity to determine periodic leg movement-related arousals.

14. The method of claim 1, and further comprising the additional step of determining a patient'"'"'s sleep state and regulating treatment based on a patient'"'"'s sleep state.

15. The method of claim 1, and wherein the step of determining includes detecting a change in measure of residual carbon dioxide levels, residual nitric oxide levels, or residual oxygen levels.

16. The method of claim 1, and further comprising the additional step of transferring data to a treatment device to enable the treatment device to determine a treatment parameter which minimizes arousals or sleep breathing disorders.

17. A method of controlling delivery of a gas to a patient comprising:

monitoring a physiological parameter;

delivering gas at a set level;

determining onset of arousal from the physiological parameter;

determining if onset of arousal is caused by upper airway resistance or gas delivery; and

adjusting the level of delivered gas based on whether the arousal is attributed to upper airway resistance or gas delivery.

18. The method of claim 17, and further comprising using a forced oscillation treatment to determine threshold levels for arousal.

19. The method of claim 17, and further comprising the additional step of determining the onset of Respiratory Effort Related arousal.

20. The method of claim 17, and further comprising the step of determining the onset of obstructive sleep apnea-hypopnea.

21. The method of claim 17, and further comprising providing a table having a plurality of entries which define an onset of an event based on a set of values for a plurality of different monitored physiological parameters.

22. The method of claim 17, and further comprising the additional step of adjusting the pressure level of the delivered gas based on an index value derived from at least one of the plurality of monitored physiological parameters.

23. The method of claim 17, and further comprising the step of determining sleep quality.

24. The method of claim 17, and further comprising the step of determining cheynes-stokes respiration.

25. The method of claim 17, and further comprising providing a table linking a plurality of values from the monitored parameters to an event, and updating the table to accommodate a patient'"'"'s sensitivity.

26. The method of claim 17, wherein the step of determining includes high bandwidth monitoring of airflow waveforms or pressure waveforms to determine arousal or sleep breathing disorders.

27. The method of claim 17, wherein the step of determining includes analyzing pulse transit time, blood pressure, and ECG signals to determine the onset of arousal.

28. The method of claim 17, wherein the step of determining includes analyzing a patient'"'"'s breath to determine a periodic breathing event.

29. The method of claim 17, and further comprising the step of determining the existence of oral breathing and wherein the step of adjusting includes compensating for oral breathing.

30. An apparatus comprising:

a sensor for detecting a physiological signal;

a therapeutic device having an adjustable treatment level; and

a controller in communication with the sensor and the therapeutic device, the controller adapted to detect onset of arousal from the detected physiological signal and to adjust treatment level to avoid arousal.

31. The apparatus of claim 30, wherein the therapeutic device is a gas delivery device.

32. The apparatus of claim 30, wherein the therapeutic device is an infusion device.

33. The apparatus of claim 30, wherein the therapeutic device is a cardiac pacemaker system.

34. The apparatus of claim 30, and further comprising a memory device containing a table correlating the values of a plurality of physiological parameters to onset of arousal.

35. The apparatus of claim 30, and further comprising a memory device containing a table correlating onset of arousal with an appropriate treatment level.

36. The apparatus of claim 30, wherein the controller is also adapted to predict the onset of obstruction sleep apnea-hypopnea.

37. The apparatus of claim 30, wherein the controller is also adapted to perform a test varying treatment level to determine sensitivity of patient to treatment related arousal.

38. The apparatus of claim 30, wherein the controller is also adapted to monitor sleep quality.

39. The apparatus of claim 30, wherein the controller is also adapted to create an index value from a plurality of different physiological signals and to adjust the treatment level based on the index value.

40. An apparatus comprising:

a plurality of sensors for monitoring a plurality of physiological signals;

a processor adapted to detect an onset of arousal from the plurality of physiological signals.

41. The apparatus of claim 40, wherein the sensors include EEG sensors.

42. The apparatus of claim 40, wherein the sensor includes EMG sensors.

43. The apparatus of claim 40, wherein the sensors include an airflow sensor.

44. The apparatus of claim 40, wherein the sensors include an ECG sensor and an SpO₂ sensor and wherein the processor is adapted to calculate PTT.

45. The apparatus of claim 40, wherein the sensors include a body position sensor.

46. The apparatus of claim 40, wherein the processor is adapted to test a patient'"'"'s sensitivity to arousal.

47. The apparatus of claim 40, and further comprising a memory device adapted to store values for physiological parameters that indicate arousal for a particular patient.

48. The apparatus of claim 40, and further comprising a memory device, and wherein the processor is adapted to store the physiological signals in the memory device.

49. The apparatus of claim 40, wherein the processor is adapted to display raw data and derived indexes from the physiological parameters according to user selected formats.

50. A gas delivery device comprising:

a plurality of sensors for monitoring a plurality of physiological parameters;

a gas delivery device having an adjustable pressure level; and

a controller in communication with the sensor and the gas delivery device, the controller adapted to determine onset of arousal resulting from RERA or from TERA, and to adjust the pressure level of the gas delivery device accordingly.

51. The gas delivery device of claim 50, wherein the gas delivery device is a CPAP machine.

52. The gas delivery device of claim 50, wherein the gas delivery device is a ventilator.

53. The gas delivery device of claim 50, wherein the gas delivery device is an oxygen concentrator.

54. The gas delivery device of claim 50, wherein the controller is also adapted to obtain and store patient-specific physiological parameters which indicate the onset of arousal.

55. The gas delivery device of claim 50, wherein the plurality of sensors communicate with the controller utilizing a wireless technology.

56. A drug delivery apparatus comprising:

plurality of sensors;

a drug delivery device having an adjustable drug delivery level; and

a controller in communication with the sensors and the drug delivery device, the controller adapted to adjust the drug delivery level based on a patient'"'"'s sleep state.

57. A cardiac pacing system comprising:

a plurality of sensors;

a pacing device having an adjustable output control; and

a controller in communication with the sensors and the pacing device, the controller adapted to adjust the output of the pacing device to minimize arousal.