Detecting, assessing, and diagnosing sleep apnea

• US 20030176788A1
• Filed: 01/28/2003
• Published: 09/18/2003
• Est. Priority Date: 01/28/2002
• Status: Abandoned Application

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Crutchfield, Kevin E., Mozayeni, B. Robert, Beckman, Robert, Beckman, Luke
• Application Number:
  US10/352,245
• Publication Number:
  US 20030176788A1
• Time in Patent Office: Days
• US Class Current: 600/437
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain

Abstract

The present invention comprises methods for detecting, assessing, diagnosing, and pre-diagnosing sleep apnea, and for assessing the efficacy of a treatment for sleep apnea. Methods for the detection, assessment, diagnosis and pre-diagnosis (screening) of sleep apnea and the assessment of a treatment for sleep apnea according to the present invention may be performed in the absence of a sleep study. The patients subject to these methods may remain awake during their performance. The invention may be applied to other vascular conditions besides sleep apnea, wherein the sleep apnea methods described herein are example methods for the application of the present invention to the detection, assessment, diagnosis and pre-diagnosis (screening) of other vascular conditions.

Claims

1. A method of diagnosing or assessing sleep apnea comprising the steps of:

referencing one or more blood flow values for each of one or more patient vessels;

referencing one or more blood flow values for each of one or more reference population vessels, wherein the one or more reference population vessels are corresponding vessels to the one or more patient vessels;

statistically analyzing the difference in the one or more blood flow values for each one or more patient vessels from the one or more blood flow values for each one of the corresponding one or more reference population vessels; and

determining whether sleep apnea exists or to what extent sleep apnea exists in a patient based on said difference.

2. The method of diagnosing or assessing sleep apnea according to claim 1, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels comprise one or more of:

systolic acceleration, mean flow velocity, and pulsatility index.

3. The method of diagnosing or assessing sleep apnea according to claim 2, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels comprise systolic acceleration, and wherein said difference comprises a systolic acceleration for each one or more patient vessels that is less than a systolic acceleration for each one of the corresponding one or more reference population vessels.

4. The method of diagnosing or assessing sleep apnea according to claim 2, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels consist of:

systolic acceleration and mean flow velocity.

5. The method of diagnosing or assessing sleep apnea according to claim 2, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels consist of:

systolic acceleration, mean flow velocity, and pulsatility index.

6. The method of diagnosing or assessing sleep apnea according to claim 1, wherein the one or more patient vessels and the corresponding one or more reference population vessels are located in the left hemisphere of the patient'"'"'s brain.

7. The method of diagnosing or assessing sleep apnea according to claim 1, wherein the one or more patient vessels and the corresponding one or more reference population vessels comprise one or more of:

left anterior cerebral artery, left terminal carotid artery, left middle cerebral artery, right carotid siphon artery, right ophthalmic artery, right vertebral artery, and basilar artery.

8. The method of diagnosing or assessing sleep apnea according to claim 7, wherein the one or more patient vessels and the corresponding one or more reference population vessels comprise one or more of:

left terminal carotid artery, left middle cerebral artery, right ophthalmic artery, and basilar artery.

9. The method of diagnosing or assessing sleep apnea according to claim 7, wherein the one or more patient vessels and the corresponding one or more reference population vessels consist of:

left terminal carotid artery, left middle cerebral artery, right ophthalmic artery, and basilar artery.

10. The method of diagnosing or assessing sleep apnea according to claim 1 further comprising the step of:

referencing a sleep study performed on the patient, and wherein the step of determining whether sleep apnea exists or to what extent sleep apnea exists in a patient is based on said difference and on the sleep study.

11. The method of diagnosing or assessing sleep apnea according to claim 1, wherein the step of statistically analyzing the difference in blood flow values comprises one or more of a centroid analysis, a parametric test, or a non-parametric test.

12. The method of diagnosing or assessing sleep apnea according to claim 1 further comprising the step of:

calculating the one or more blood flow values for the one or more patient vessels from patient blood flow data.

13. The method of diagnosing or assessing sleep apnea according to claim 12 further comprising the step of:

collecting the patient blood flow data from a patient.

14. The method of diagnosing or assessing sleep apnea according to claim 13 further comprising the step of:

collecting the patient blood flow data using vascular Doppler ultrasound.

15. The method of diagnosing or assessing sleep apnea according to claim 12 further comprising the step of:

calculating the one or more blood flow values for the one or more reference population vessels from reference population blood flow data.

16. The method of diagnosing or assessing sleep apnea according to claim 15 further comprising the step of:

collecting the reference population blood flow data from one or more subjects from a general population.

17. The method of diagnosing or assessing sleep apnea according to claim 16 further comprising the step of:

collecting the reference population blood flow using vascular Doppler ultrasound.

18. The method of diagnosing or assessing of diagnosing sleep apnea according to claim 1, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels are calculated from blood flow data, and wherein the blood flow data is collected using a means for vascular imaging.

19. The method of diagnosing or assessing of diagnosing sleep apnea according to claim 18, wherein the means for vascular imaging comprises a vascular Doppler ultrasound probe.

20. The method of diagnosing or assessing of diagnosing sleep apnea according to claim 1, wherein the method is performed while the patient is awake.

21. A method of diagnosing or assessing a vascular disease comprising the steps of:

referencing one or more blood flow values for each of one or more patient vessels;

referencing one or more blood flow values for each of one or more reference population vessels, wherein the one or more reference population vessels are corresponding vessels to the one or more patient vessels;

statistically analyzing the difference in the one or more blood flow values for each one or more patient vessels from the one or more blood flow values for each one of the corresponding one or more reference population vessels; and

determining whether a vascular disease exists or to what extent sleep apnea exists in a patient based on said difference;

wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels are calculated from blood flow data, and wherein the blood flow data is collected using vascular Doppler ultrasound.

22. The method of diagnosing or assessing a vascular disease according to claim 21, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels comprise one or more of:

systolic acceleration, mean flow velocity, and pulsatility index.

23. The method of diagnosing or assessing a vascular disease according to claim 22, wherein the blood flow values referenced for both the one or more patient vessels and the one or more reference population vessels consist of:

systolic acceleration, mean flow velocity, and pulsatility index.

24. The method of diagnosing or assessing a vascular disease according to claim 21, wherein the step of statistically analyzing the difference in blood flow values comprises one or more of a centroid analysis, a parametric test, or a non-parametric test.

25. The method of diagnosing or assessing a vascular disease according to claim 21, wherein the vascular disease is sleep apnea.

26. The method of diagnosing or assessing a vascular disease according to claim 21, wherein the vascular disease is stroke.

27. The method of diagnosing or assessing of diagnosing sleep apnea according to claim 21, wherein the method is performed while the patient is awake.

28. A method of assessing the effectiveness of a treatment for sleep apnea comprising the steps of:

referencing one or more first blood flow values for each of one or more patient vessels, the first patient vessel values being calculated before the administration of a treatment;

referencing one or more second blood flow values for each of one or more patient vessels, the second patient vessel values being calculated after the administration of a treatment;

statistically analyzing the difference in the one or more first blood flow values from the one or more second blood flow values; and

determining the effectiveness of the treatment based on said difference;

wherein the one or more first blood flow values and the one or more second blood flow values are calculated from blood flow data, and wherein the blood flow data is collected using vascular Doppler ultrasound.

29. The method of assessing the effectiveness of a treatment for sleep apnea according to claim 28, wherein the blood flow values referenced both before and after the administration of the treatment comprise one or more of:

systolic acceleration, mean flow velocity, and pulsatility index.

30. The method of assessing the effectiveness of a treatment for sleep apnea according to claim 29, wherein the blood flow values referenced both before and after the administration of the treatment consist of:

systolic acceleration, mean flow velocity, and pulsatility index.

31. The method of assessing the effectiveness of a treatment for sleep apnea according to claim 28, wherein the step of statistically analyzing the difference in blood flow values comprises one or more of a centroid analysis, a parametric test, or a non-parametric test.

32. The method of assessing the effectiveness of a treatment according to claim 28, wherein the one or more patient vessels are located in the left hemisphere of the patient'"'"'s brain.

33. The method of assessing the effectiveness of a treatment according to claim 28, wherein the one or more patient vessels comprise one or more of:

left anterior cerebral artery, left terminal carotid artery, left middle cerebral artery, right carotid siphon artery, right ophthalmic artery, right vertebral artery, and basilar artery.

34. The method of assessing the effectiveness of a treatment according to claim 33, wherein the one or more patient vessels comprise one or more of:

left terminal carotid artery, left middle cerebral artery, right ophthalmic artery, and basilar artery.

35. The method of assessing the effectiveness of a treatment according to claim 34, wherein the one or more patient vessels consist of:

left terminal carotid artery, left middle cerebral artery, right ophthalmic artery, and basilar artery.

36. The method of assessing the effectiveness of a treatment according to claim 28, wherein the method is performed while the patient is awake.

37. A method of diagnosing or assessing sleep apnea in a patient comprising the steps of:

referencing one or more blood flow values of the patient;

referencing one or more blood flow values for a reference population, wherein the one or more reference population blood flow values correspond to the one or more patient blood flow values;

statistically analyzing the difference between the one or more patient blood flow values and the one or more corresponding reference population blood flow values; and

determining whether sleep apnea exists or to what extent sleep apnea exists in a patient based on said difference;

wherein the patient is awake.

38. The method of diagnosing or assessing sleep apnea according to claim 37, wherein the one or more patient blood flow values and the corresponding one or more reference population blood flow values are derived from cerebrovascular data.

39. The method of diagnosing or assessing sleep apnea according to claim 38, wherein the cerebrovascular data is vascular Doppler ultrasound data.

40. The method of diagnosing or assessing sleep apnea according to claim 38, wherein the cerebrovascular data is collected from the left hemisphere of the patient'"'"'s brain.

41. The method of diagnosing or assessing sleep apnea according to claim 38, wherein the cerebrovascular data is collected from one or more of:

left terminal carotid artery, left middle cerebral artery, right ophthalmic artery, and basilar artery.

42. The method of diagnosing or assessing sleep apnea according to claim 37, wherein the one or more patient blood flow values and the corresponding one or more reference population blood flow values comprise one or more of systolic acceleration, mean flow velocity, and pulsatility index.