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NCT Number: NCT06311045

Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
  • HbA1c <6.5%

Exclusion criteria

  • Body mass index (BMI) ≥40 kg/m2;
  • Diagnosis of diabetes mellitus, defined as the use of any diabetes medication (including glucagon like peptide [GLP]-1 agonists) currently or in the previous three months or HbA1c ≥6.5%;
  • Shift work (i.e., working hours that routinely cause sleep initiation after 1:00 a.m.);
  • Another major sleep disorder (i.e., circadian rhythm disorder, any history of narcolepsy, concurrently diagnosed or medication-treated restless legs syndrome, concurrently diagnosed or medication-treated chronic insomnia with the exception of antidepressant therapy);
  • Regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, or prescription sleep medication other than antidepressants currently or within the last month;
  • The use of N-acetylcysteine in any form (oral, intravenous, inhaled) in the last seven days
  • The use of other over-the-counter antioxidant therapies including vitamin C or vitamin E in the preceding 10 days
  • History of reduced ejection fraction heart failure, or chronic cardiac arrhythmia requiring medication or treatment;
  • Unstable or uncontrolled medical or psychiatric comorbidity requiring hospitalization or change in medication during the previous three months;
  • Use of biologics or immune modulators in the last year;
  • Use of systemic steroids during the previous three months;
  • Current tobacco smoking;
  • Inability to sign informed consent;
  • Currently use of positive airway pressure therapy or another OSA treatment (e.g., hypoglossal nerve stimulator, oral device);
  • Recent history of alcoholism or drug abuse (within the last three months)
  • Neurological condition that requires ongoing pharmacological therapy (e.g., Parkinson's disease, Alzheimer's dementia, multiple sclerosis, other degenerative neurological disease).
  • Pregnancy

Treatment and study plan

N-acetylcysteine (NAC)

Dietary Supplement

Participants will take two NAC 600mg capsules daily for four weeks.

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.

Primary outcomes

  1. Percent Change in Overnight Levels of Glutathione (GSH)

    Time frame: Baseline, Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    GSH measured using participant blood samples.

  2. Mean Change in Pre- to Post-Sleep GSH Levels

    Time frame: Baseline

    GSH measured using participant blood samples.

  3. Mean Change in Pre- to Post-Sleep GSH Levels

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    GSH measured using participant blood samples.

Secondary outcomes

  1. Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)

    Time frame: Baseline

    GSH:GSSG measured using participant blood samples.

  2. Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    GSH:GSSG measured using participant blood samples.

  3. 8-Isoprostane Level

    Time frame: Baseline

    8-isoprostane levels measured using participant blood samples.

  4. 8-Isoprostane Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    8-isoprostane levels measured using participant blood samples.

  5. Plasma Nitrate Level

    Time frame: Baseline

    Plasma nitrate levels measured using participant blood samples.

  6. Plasma Nitrate Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    Plasma nitrate levels measured using participant blood samples.

  7. Plasma Nitrite Level

    Time frame: Baseline

    Plasma nitrite levels measured using participant blood samples.

  8. Plasma Nitrite Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    Plasma nitrite levels measured using participant blood samples.

  9. Organic Nitrite Level

    Time frame: Baseline

    Organic nitrite levels measured using participant blood samples.

  10. Organic Nitrite Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    Organic nitrite levels measured using participant blood samples.

  11. Interleukin 6 (IL-6) Level

    Time frame: Baseline

    IL-6 levels measured using participant blood samples.

  12. Interleukin 6 (IL-6) Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    IL-6 levels measured using participant blood samples.

  13. Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level

    Time frame: Baseline

    TNFα-R1 levels measured using participant blood samples.

  14. Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    TNFα-R1 levels measured using participant blood samples.

  15. Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level

    Time frame: Baseline

    TNFα-R2 levels measured using participant blood samples.

  16. Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    TNFα-R2 levels measured using participant blood samples.

  17. Reactive Hyperemia Index (RHI) Score

    Time frame: Baseline

    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.

  18. Reactive Hyperemia Index (RHI) Score

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    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.

  19. Epworth Sleepiness Scale (ESS) Score

    Time frame: Baseline

    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.

  20. Epworth Sleepiness Scale (ESS) Score

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    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.

  21. Insomnia Severity Index (ISI) Score

    Time frame: Baseline

    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).

  22. Insomnia Severity Index (ISI) Score

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    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).

  23. Fatigue Severity Scale (FSS) Score

    Time frame: Baseline

    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.

  24. Fatigue Severity Scale (FSS) Score

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    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.

  25. Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Baseline

    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.

  26. Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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