# US 9,435,814 B2 · Methods and kits for diagnosing obstructive sleep apnea

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- Number: US 9,435,814 B2
- Document ID: US9435814B2
- Status: Granted
- Kind: B2
- Application number: 14/641,006
- Filed: 2015-03-06
- Published: 2015-06-25
- Granted: 2016-09-06
- Earliest claimed: 2008-09-26
- Assignees: University of Louisville Research Foundation, Inc.
- Applicants: University of Louisville Research Foundation, Inc.
- Inventors: David Gozal; Saeed A. Jortani; Roland Valdes, Jr.; Leila Kheirandish-Gozal
- Web page: https://patentgrep.com/patent/US9435814B2

## CPC

- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- G01N 2800/2864: Sleep disorders
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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

### Claim 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 increase in the amount of the Urocortin III peptide in the sample as compared to the control level,
wherein determining the amount in the sample of the Urocortin III peptide comprises determining the amount in the sample using mass spectrometry (MS) analysis, immunoassay analysis, or both,
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), and
wherein the immunoassay analysis is selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoturbidimetric assay.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 3)

The method of claim 3, wherein the subject is human and under the age of about 9 to about 2 years of age.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8

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,
wherein analyzing the series of biological samples to determine the amount in each of the biological samples of the Urocortin III peptide comprises determining the amount in the sample using mass spectrometry analysis, immunoassay analysis, or both,
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), and
wherein the immunoassay analysis is selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA) and an immunoturbidimetric assay.

### Claim 9 (depends on 8)

The method of claim 8, wherein the biological sample comprises urine, saliva, blood, plasma, or serum.

### Claim 10 (depends on 8)

The method of claim 8, wherein the subject is human.

### Claim 11 (depends on 8)

The method of claim 8, wherein the subject is human and under the age of about 9 to about 2 years of age.

### Claim 12 (depends on 8)

The method of claim 8, 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.

### Claim 13 (depends on 8)

The method of claim 8, 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.

### Claim 14 (depends on 8)

The method of claim 8, 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.