Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percent Change in Overnight Levels of Glutathione (GSH)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
- •HbA1c <6.5%
排除标准
- •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
研究组 & 干预措施
Placebo
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.
干预措施: Placebo (Dietary Supplement)
NAC
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.
干预措施: N-acetylcysteine (NAC) (Dietary Supplement)
NAC
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.
干预措施: Positive Airway Pressure (PAP) Therapy (Procedure)
Placebo
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.
干预措施: Positive Airway Pressure (PAP) Therapy (Procedure)
结局指标
主要结局
Percent Change in Overnight Levels of Glutathione (GSH)
时间窗: 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
时间窗: 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
时间窗: Baseline
GSH measured using participant blood samples.
次要结局
- Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- 8-Isoprostane Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Organic Nitrite Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Interleukin 6 (IL-6) Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Plasma Nitrate Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Plasma Nitrite Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Reactive Hyperemia Index (RHI) Score(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Epworth Sleepiness Scale (ESS) Score(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Pittsburgh Sleep Quality Index (PSQI) Score(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Insomnia Severity Index (ISI) Score(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Fatigue Severity Scale (FSS) Score(Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6))
- Organic Nitrite Level(Baseline)
- Interleukin 6 (IL-6) Level(Baseline)
- Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)(Baseline)
- 8-Isoprostane Level(Baseline)
- Plasma Nitrate Level(Baseline)
- Plasma Nitrite Level(Baseline)
- Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level(Baseline)
- Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level(Baseline)
- Reactive Hyperemia Index (RHI) Score(Baseline)
- Epworth Sleepiness Scale (ESS) Score(Baseline)
- Insomnia Severity Index (ISI) Score(Baseline)
- Fatigue Severity Scale (FSS) Score(Baseline)
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline)