METHODS AND KITS FOR DIAGNOSING OBSTRUCTIVE SLEEP APNEA

• US 20110217719A1
• Filed: 09/25/2009
• Published: 09/08/2011
• Est. Priority Date: 09/26/2008
• Status: Active Grant

• Current Assignee: University of Louisville
• Original Assignee: University of Louisville
• Inventors: Gozal, David, Jortani, Saeed A., Kheirandish-Gozal, Leila, Valdes, Roland JR.
• Granted Patent: US 8,999,658 B2
• Time in Patent Office: Days
• US Class Current: 435/7.4
• CPC Class Codes: G01N 2800/2864 Sleep disorders
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease

Abstract

The presently-disclosed subject matter provides methods and kits for diagnosing obstructive sleep apnea (OSA) in a subject, such as a human child, wherein a biological sample is provided from the subject and the amount of a Urocortin III peptide is determined from the sample. Further provided are methods for diagnosing OSA in a subject wherein the amount of a Urocortin III peptide and one or more peptides selected from a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide are determined in a biological sample from a subject.

Claims

1. A method for diagnosing obstructive sleep apnea in a subject, comprising:

(a) providing a biological sample from the subject;

(b) determining an amount in the sample of a Urocortin III peptide; and

(c) comparing the amount of the Urocortin III peptide in the sample, if present, to a control level of the Urocortin III peptide, wherein the subject is diagnosed as having obstructive sleep apnea if there is a measurable difference in the amount of the Urocortin III peptide in the sample as compared to the control level.

2. The method of claim 1, further comprising providing an apparatus capable of detecting the Urocortin III peptide.

3. The method of claim 1, further comprising providing a probe for selectively binding the Urocortin III peptide.

4. The method of claim 1, wherein the biological sample comprises urine, saliva, blood, plasma, or serum.

5. The method of claim 1, wherein the subject is human.

6. The method of claim 5, wherein the subject is human and under the age of about 9 to about 2 years of age.

7. The method of claim 1, wherein determining the amount in the sample of the Urocortin III peptide comprises determining the amount in the sample of the Urocortin III peptide using mass spectrometry (MS) analysis, immunoassay analysis, or both.

8. The method of claim 7, wherein the mass spectrometry (MS) analysis is selected from the group consisting of liquid-chromatography mass spectrometry (LC-MS), electrospray ionization mass spectrometry (ESI-MS), matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF-MS), and surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS).

9. The method of claim 7, wherein the immunoassay analysis is selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoturbidimetric assay.

10. The method of claim 1, further comprising determining an amount in the sample of one or more peptides selected from the group consisting of:

a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.

11. The method of claim 1, further comprising determining an amount in the sample of a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.

12. The method of claim 1, further comprising selecting a treatment or modifying a treatment for the obstructive sleep apnea based on the determined amount of the Urocortin III peptide.

13. A method for determining whether to initiate or continue prophylaxis or treatment of obstructive sleep apnea in a subject, comprising:

(a) providing a series of biological samples over a time period from the subject;

(b) analyzing the series of biological samples to determine an amount in each of the biological samples of a Urocortin III peptide; and

(c) comparing any measurable change in the amounts of the Urocortin III peptide in each of the biological samples to thereby determine whether to initiate or continue the prophylaxis or therapy of the obstructive sleep apnea.

14. The method of claim 13, wherein the biological sample comprises urine, saliva, blood, plasma, or serum.

15. The method of claim 13, wherein the subject is human.

16. The method of claim 15, wherein the subject is human and under the age of about 9 to about 2 years of age.

17. The method of claim 13, wherein determining the amount in the sample of the Urocortin III peptide comprises determining the amount in the sample of the Urocortin III peptide using mass spectrometry (MS) analysis, immunoassay analysis, or both.

18. The method of claim 17, wherein the mass spectrometry (MS) analysis is selected from the group consisting of liquid-chromatography mass spectrometry (LC-MS), electrospray ionization mass spectrometry (ESI-MS), matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF-MS), and surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS).

19. The method of claim 17, wherein the immunoassay analysis is selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoturbidimetric assay.

20. The method of claim 13, wherein the series of biological samples comprises a first biological sample collected prior to initiation of the prophylaxis or treatment for the obstructive sleep apnea and a second biological sample collected after initiation of the prophylaxis or treatment.

21. The method of claim 13, further comprising analyzing the series of biological samples to determine an amount in each of the biological samples of one or more peptides selected from the group consisting of:

a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.

22. The method of claim 13, further comprising analyzing the series of biological samples to determine an amount in each of the biological samples of a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.

23. A kit for diagnosing obstructive sleep apnea in a subject, the kit comprising one or more antibodies capable of detecting a Urocortin III peptide in a biological sample obtained from a subject and instructions for using the kit.

24. The kit of claim 23, wherein the subject is human.

25. The kit of claim 24, wherein the subject is human and under the age of about 9 to about 2 years of age.

26. The kit of claim 23, further comprising one or more antibodies capable of detecting one or more peptides selected from the group consisting of:

a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.

27. The kit of claim 23, further comprising antibodies capable of detecting a Uromodulin peptide, an Orosomucoid 1 peptide, and a Kallikrein 1 peptide.