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Development and Validation of a Nocturnal Sleep Signature for the Diagnosis of Idiopathic Hypersomnia

Award Number: R61NS130215
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Development and Validation of a Nocturnal Sleep Signature for the Diagnosis of Idiopathic Hypersomnia - Abstract Idiopathic hypersomnia (IH) is a chronic, disabling central nervous system disorder of hypersomnolence that typically begins in adolescence. Progress in understanding IH pathophysiology and identifying effective treatments is stymied by the commonly used diagnostic test, the multiple sleep latency testing (MSLT). This test is very reliable in classic narcolepsy but has poor validity and reliability in people with IH. In addition to this poor clinical performance, the current diagnostic use of the MSLT also hinders clinical trials by enrollment of clinically heterogeneous IH cohorts with more variable outcomes. Thus, there is a critical need to develop and validate an objective IH biomarker signature to improve diagnostic accuracy. The most striking IH features occur in the nocturnal sleep period. Most IH patients report non-restorative sleep and profound difficulty waking from sleep in the morning despite normal to long sleep durations. In our prior work, we showed IH is characterized by shorter (less stable) bouts of NREM 3 (N3) sleep (the most restorative sleep stage), longer bouts of less refreshing NREM 2 (N2) sleep, long sleep times, and high sleep efficiency. These findings may reflect proposed mechanisms of IH including heightened GABA receptor potentiation or prolonged circadian period. As a multi-disciplinary team with expertise in modeling neurophysiological processes, biomarker discovery, statistics, and hypersomnia disorders, we hypothesize that measures of nocturnal sleep stability will define the IH signature and more accurately identify IH than the current MSLT method. In the R61 grant, our objectives are to: (Aim 1) identify nocturnal sleep features of hypersomnia patients using polysomnograms retained in the National Sleep Research Resource; (Aim 2) develop and test a sleep biomarker signature from polysomnogram signals (IH signature) for IH diagnosis in a clinical population across 5 sites using current diagnostic criteria and cutoff scores on validated IH symptom scales as the “gold standard” IH classification. In meeting our robust “go criteria” showing high sensitivity and specificity of our IH signature for IH diagnosis, we will proceed with the R33 phase. In this next grant phase, we will validate the IH signature in a separate and new clinical cohort of patients (Aim 3) and test the reliability of the IH signature (Aim 4). Through this work, we will identify an accurate and stable biomarker signature that will provide more accurate diagnosis of IH using nocturnal PSG testing. This will improve diagnostic certainty in the clinic and reduce clinical heterogeneity for research, enabling study of underlying causal mechanisms and future drug development.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $465,931 )
2026	2026	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	5/18/2026	NON-COMPETING CONTINUATION	$465,931
														Subtotal = $465,931

Issue Date FY: 2025 ( Subtotal = $731,511 )
2025	2025	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	5/20/2025	NON-COMPETING CONTINUATION	$731,511
2025	2025	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	5/29/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $731,511

Issue Date FY: 2024 ( Subtotal = $785,153 )
2024	2024	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	5/31/2024	NEW	$3,428
2024	2024	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	5/3/2024	NEW	$781,725
														Subtotal = $785,153

Grand Total All Awards = $1,982,595

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Development and Validation of a Nocturnal Sleep Signature for the Diagnosis of Idiopathic Hypersomnia

Award Number: R61NS130215

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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