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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC | Experimental | Following run-in PAP therapy per standard clinical care for 12 weeks, participants randomized to the NAC arm will also receive the supplement N-acetylcysteine (NAC) for four weeks while remaining on PAP therapy. |
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| Placebo | Experimental | Following run-in PAP therapy per standard clinical care for 12 weeks, participants randomized to the placebo arm will also receive placebo for four weeks while remaining on PAP therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine (NAC) | Dietary Supplement | Participants will take two NAC 600mg capsules daily for four weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Overnight Levels of Glutathione (GSH) | GSH measured using participant blood samples. | Baseline, Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Mean Change in Pre- to Post-Sleep GSH Levels | GSH measured using participant blood samples. | Baseline |
| Mean Change in Pre- to Post-Sleep GSH Levels | GSH measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) | GSH:GSSG measured using participant blood samples. | Baseline |
| Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) | GSH:GSSG measured using participant blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Nisha Aurora, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Rashmi.aurora@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Requests should be directed to Rashmi.aurora@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The investigator who proposed to use the data will be granted access upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2025 | Mar 30, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Dietary Supplement | Participants will take two placebo 600mg capsules daily for four weeks. |
|
| Positive Airway Pressure (PAP) Therapy | Procedure | All participants will receive PAP therapy per standard of care for OSA. |
|
| Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| 8-Isoprostane Level | 8-isoprostane levels measured using participant blood samples. | Baseline |
| 8-Isoprostane Level | 8-isoprostane levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Plasma Nitrate Level | Plasma nitrate levels measured using participant blood samples. | Baseline |
| Plasma Nitrate Level | Plasma nitrate levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Plasma Nitrite Level | Plasma nitrite levels measured using participant blood samples. | Baseline |
| Plasma Nitrite Level | Plasma nitrite levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Organic Nitrite Level | Organic nitrite levels measured using participant blood samples. | Baseline |
| Organic Nitrite Level | Organic nitrite levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Interleukin 6 (IL-6) Level | IL-6 levels measured using participant blood samples. | Baseline |
| Interleukin 6 (IL-6) Level | IL-6 levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level | TNFα-R1 levels measured using participant blood samples. | Baseline |
| Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level | TNFα-R1 levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level | TNFα-R2 levels measured using participant blood samples. | Baseline |
| Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level | TNFα-R2 levels measured using participant blood samples. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Reactive Hyperemia Index (RHI) Score | RHI is a measure of endothelial-dependent vasodilation and is assessed using a noninvasive vascular tone measure (EndoPAT®). RHI reflects endothelial health, with lower scores signifying more dysfunction. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. | Baseline |
| Reactive Hyperemia Index (RHI) Score | RHI is a measure of endothelial-dependent vasodilation and is assessed using a noninvasive vascular tone measure (EndoPAT®). RHI reflects endothelial health, with lower scores signifying more dysfunction. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Epworth Sleepiness Scale (ESS) Score | ESS is an 8-item questionnaire assessing usual likelihood of falling asleep during each of eight common activities. Each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0-24; higher scores indicate greater subjective daytime sleepiness. | Baseline |
| Epworth Sleepiness Scale (ESS) Score | ESS is an 8-item questionnaire assessing usual likelihood of falling asleep during each of eight common activities. Each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0-24; higher scores indicate greater subjective daytime sleepiness. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Insomnia Severity Index (ISI) Score | ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a 5-point Likert scale from 0-4. The total score is the sum of responses and ranges from 0-28. Scores are interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); or severe insomnia (21-28). | Baseline |
| Insomnia Severity Index (ISI) Score | ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a 5-point Likert scale from 0-4. The total score is the sum of responses and ranges from 0-28. Scores are interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); or severe insomnia (22-28). | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Fatigue Severity Scale (FSS) Score | FSS is a 9-item measure of fatigue severity from a variety of medical and neurological disorders. Each item is rated on a Likert scale from 1-7. The total score is the sum of responses and ranges from 9-63, with higher scores indicating greater fatigue. | Baseline |
| Fatigue Severity Scale (FSS) Score | FSS is a 9-item measure of fatigue severity from a variety of medical and neurological disorders. Each item is rated on a Likert scale from 1-7. The total score is the sum of responses and ranges from 9-63, with higher scores indicating greater fatigue. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| Pittsburgh Sleep Quality Index (PSQI) Score | PSQI is a 19-item questionnaire that is routinely used in both clinical and research settings to assess sleep quality over the preceding one month. The total score ranges from 0-21, with higher scores reflecting worse sleep quality. | Baseline |
| Pittsburgh Sleep Quality Index (PSQI) Score | PSQI is a 19-item questionnaire that is routinely used in both clinical and research settings to assess sleep quality over the preceding one month. The total score ranges from 0-21, with higher scores reflecting worse sleep quality. | Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6) |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |