Back to results
US 2018/0003723 A1Published application
Methods and systems for diagnosing sleep disorders
OwnerBalwant Rai, Jasdeep Kaurinventors
Life of this patent
Estimating the term…
Abstract
Methods and compositions for risk detection, early diagnosis, prognosis, and monitoring of sleepiness in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with sleepiness, or an earlier sample from the individual of interest.
Claims20
A method of diagnosing sleepiness, comprising:
- (a) collecting a saliva sample from an individual suspected of suffering a sleep disorder;
- (b) applying the saliva sample to a solid support on which at least two agents, each of which binds to a different single biomarker selected from arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin I, BDNF, 3-methyl-1-oxo-butyrate, or linolenate have been affixed, and wherein each agent binds to the different single biomarker to form a measurable complex of a single biomarker;
- (c) measuring the measurable complex of each of the different single biomarkers to create an individual biomarker profile;
- and
- (d) comparing the individual biomarker profile to reference levels for each of the different single biomarkers, wherein the individual biomarker profile meeting two or more criteria in a group of criteria is indicative of the sleep disorder, the group of criteria consisting of:
- an arginine reference level greater than about 0.32 μmol/ml,
- a creatine reference level greater about 0.47 μmol/ml,
- a dihomo-linoleate reference level greater than about 34 μmol/ml,
- a tyrosine reference level greater than about 0.57 μmol/ml,
- a beta-endorphin reference level greater than about 1490 pg/ml,
- a BDNF reference level greater than about 488 pg/ml,
- a 3-methyl-oxobutyrate reference level greater than about 52 μmol/ml,
- a linoleate reference level greater than about 36 μmol/ml,
- chromogranin A reference level greater than about 3.3 μmol/mg protein, and
- an annexin I reference level greater than about 55 ng/ml.
12 more elements
A method of monitoring effectiveness of a treatment for a sleep disorder comprising:
- (a) collecting a first saliva sample from an individual diagnosed with the sleep disorder;
- (b) applying the first saliva sample to a first solid support on which a plurality of agents, which in combination bind to at least two different single biomarkers selected from selected from arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin I, BDNF, 3-methyl-1-oxo-butyrate, or linolenate have been affixed;
- wherein each agent binds to the different single biomarker to form a measurable complex of the each of the different single biomarkers;
- (c) measuring the measurable complex of each of the different single biomarkers selected from arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin I, BDNF, 3-methyl-1-oxo-butyrate, or linolenate in the first saliva sample to create a first individual biomarker profile;
- (d) treating the individual for the sleep disorder;
- (e) collecting a second saliva sample from the individual diagnosed with the sleep disorder at a time point after the treatment for the sleep disorder has begun;
- (f) applying the second saliva sample to a second solid support on which the plurality of agents which bind to the different single biomarker on the first solid support have been affixed to form a measurable complex of each of the different single biomarkers;
- (g) measuring levels of each of the different single biomarkers selected from arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin I, BDNF, 3-methyl-1-oxo-butyrate, or linolenate in the second saliva sample to create a second individual biomarker profile;
- and
- (h) comparing the first individual biomarker profile and the second individual biomarker profile, wherein a decrease in levels of arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin I, BDNF, 3-methyl-1-oxo-butyrate, or linolenate in the second individual biomarker profile relative to the first individual biomarker profile indicates that the treatment is effective.
7 more elements
A kit for determining whether a patient has a sleep disorder comprising:
- a plurality of test strips, each configured to produce a fluorescence level proportional to an amount present on one of the plurality of test strips of at least two biomarkers selected from arginine, creatine, dihomo-linoleate, tyrosine, beta-endorphin, chromogranin A, annexin 1, BDNF, 3-methyl-1-oxo-butyrate, or linolenate;
- and
- a reading device configured to read the fluorescence level proportional to the level of each biomarker on each of the plurality of test strips after each of the plurality of test strips are exposed to a saliva sample and wherein when the fluorescence levels on the plurality of test strips indicate that two or more of the biomarkers meet two or more criteria in a group of criteria, the group of criteria consisting of:
- an arginine reference level greater than about 0.32 μmol/ml,
- a creatine reference level greater about 0.47 μmol/ml,
- a dihomo-linoleate reference level greater than about 34 μmol/ml,
- a tyrosine reference level greater than about 0.57 μmol/ml,
- a beta-endorphin reference level greater than about 1490 pg/ml,
- a BDNF reference level greater than about 488 pg/ml,
- a 3-methyl-oxobutyrate reference level greater than about 52 μmol/ml,
- a linoleate reference level greater than about 36 μmol/ml,
- a chromogranin A reference level greater than about 3.3 μmol/mg protein, and
- an annexin I reference level greater than about 55 ng/ml.
10 more elements
Dependencies are inferred from the claim text.