Obstructive Sleep ApneaNCT06311045
Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)
A study testing N-acetylcysteine (NAC) and Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- N-acetylcysteine (NAC) and Positive Airway Pressure (PAP) Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
- HbA1c <6.5%
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- N-acetylcysteine (NAC), Placebo, Positive Airway Pressure (PAP) Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine (NAC)Dietary supplement
Participants will take two NAC 600mg capsules daily for four weeks.
PlaceboDietary supplement
Participants will take two placebo 600mg capsules daily for four weeks.
Positive Airway Pressure (PAP) TherapyProcedure or surgery
All participants will receive PAP therapy per standard of care for OSA.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: N-acetylcysteine (NAC); Procedure: Positive Airway Pressure (PAP) Therapy |
| 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. Receives: Dietary Supplement: Placebo; Procedure: Positive Airway Pressure (PAP) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Overnight Levels of Glutathione (GSH)
GSH measured using participant blood samples.
Measured: 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.
Measured: Baseline
Mean Change in Pre- to Post-Sleep GSH Levels
GSH measured using participant blood samples.
Measured: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Secondary outcomes (26)
Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)
GSH:GSSG measured using participant blood samples.
Measured: Baseline
Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)
GSH:GSSG measured using participant blood samples.
Measured: 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.
Measured: Baseline
8-Isoprostane Level
8-isoprostane levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Plasma Nitrate Level
Plasma nitrate levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Plasma Nitrite Level
Plasma nitrite levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Organic Nitrite Level
Organic nitrite levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Interleukin 6 (IL-6) Level
IL-6 levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level
TNFα-R1 levels measured using participant blood samples.
Measured: 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.
Measured: Baseline
Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level
TNFα-R2 levels measured using participant blood samples.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start7 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rashmi Nisha Aurora, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311045
- Sponsor's protocol ID
- 23-01469
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06311045
- Acronym / sponsor ID
- 23-01469
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC | Experimental | Dietary Supplement: N-acetylcysteine (NAC), Procedure: Positive Airway Pressure (PAP) TherapyFollowing 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. |
| Placebo | Experimental | Dietary Supplement: Placebo, Procedure: Positive Airway Pressure (PAP) TherapyFollowing 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
- HbA1c <6.5%
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine (NAC)Participants will take two NAC 600mg capsules daily for four weeks. | Dietary supplement | NAC |
| PlaceboParticipants will take two placebo 600mg capsules daily for four weeks. | Dietary supplement | Placebo |
| Positive Airway Pressure (PAP) TherapyAll participants will receive PAP therapy per standard of care for OSA. | Procedure or surgery | NAC, Placebo |
Primary outcome
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.
Mean Change in Pre- to Post-Sleep GSH Levels
Time frame: Baseline
GSH measured using participant blood samples.
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.
26 secondary outcomes
Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)
Time frame: Baseline
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)
8-Isoprostane Level
Time frame: Baseline
8-Isoprostane Level
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Plasma Nitrate Level
Time frame: Baseline
Plasma Nitrate Level
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Plasma Nitrite Level
Time frame: Baseline
Plasma Nitrite Level
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Organic Nitrite Level
Time frame: Baseline
Organic Nitrite Level
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Interleukin 6 (IL-6) Level
Time frame: Baseline
Interleukin 6 (IL-6) Level
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level
Time frame: Baseline
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)
Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level
Time frame: Baseline
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)
Reactive Hyperemia Index (RHI) Score
Time frame: Baseline
Reactive Hyperemia Index (RHI) Score
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline
Epworth Sleepiness Scale (ESS) Score
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Insomnia Severity Index (ISI) Score
Time frame: Baseline
Insomnia Severity Index (ISI) Score
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Fatigue Severity Scale (FSS) Score
Time frame: Baseline
Fatigue Severity Scale (FSS) Score
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Nisha Aurora, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine (NAC) and Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.