APPLES: Apnea Positive Pressure Long-Term Efficacy Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,105
- 试验地点
- 10
- 主要终点
- Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR
研究概览
简要总结
The purpose of this study is to determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).
详细描述
BACKGROUND:
Nasal CPAP therapy is in widespread use as the primary treatment for OSAS, a sleep-related breathing disorder affecting more than 15 million Americans. The therapeutic effectiveness of CPAP in providing significant, stable, and long-term neurocognitive or other functional benefits to patients with OSAS has not been systematically investigated.
DESIGN NARRATIVE:
The study is a randomized, blinded, sham-controlled, multi-center trial of CPAP therapy. The principal aims of the study are: 1) to assess the long-term effectiveness of CPAP therapy on neurocognitive function, mood, sleepiness, and quality of life by administering tests of these indices to subjects randomly assigned to active or sham CPAP; 2) to identify specific neurocognitive deficits associated with OSAS in a large, heterogeneous subject population; 3) to determine which deficits in neurocognitive function in OSAS subjects are reversible and most sensitive to the effects of CPAP; 4) to develop a composite multivariate outcome measure from the results of this study that can be used to assess the clinical effectiveness of CPAP in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use functional magnetic resonance imaging to compare cortical activation before and after CPAP therapy, and to assess whether this change is associated with improvement in specific neurocognitive task performance. The primary endpoint of the study is the effect of six months of CPAP treatment on neurocognitive function. A total of 1100 subjects (550 per treatment group) will be enrolled from the patient populations at five sites (Stanford University; University of Arizona; Brigham and Women's Hospital; Massachusetts; St. Luke's Hospital, Missouri; St. Mary Medical Center, Washington).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults age 18 years or older with a diagnosis of OSAS using clinical criteria defined by the study protocol
- •Study participation may require seven or more laboratory visits over six months
排除标准
- •Prior treatment for OSAS with continuous positive airway pressure or surgery
- •Potential sleep apnea complications that may affect the health or safety of the participant, including low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, congestive heart failure, history of angina, coronary artery disease, myocardial infarction or stroke, cardiac rhythm disturbance, and chronic neurological disorders affecting neurocognitive abilities or daily function
- •The use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants or other medications likely to affect neurocognitive function and/or alertness
- •Respiratory disease requiring medications (unless on stable medications for 2 months)
- •Cancer, unless in remission for greater than one year and not taking exclusionary medications
- •Self-reported renal failure
- •Pregnancy anytime during a subject's participation
- •Psychiatric illness, as defined by a DSM-IV diagnosis, except for depression or mild anxiety
- •Narcolepsy, idiopathic hypersomnolence, DSM-IV chronic insomnia, restless legs syndrome, or rapid eye movement (REM) behavior disorder
- •Current use of diurnal or nocturnal supplemental oxygen
- •Significant vision, hearing, or coordination problems
- •Difficulty understanding or speaking English
- •Currently working night or rotating shifts
- •Consumption of more than 10 caffeinated beverages per day (approximately 1,000 mg per day)
- •Smokers whose habit interferes with the overnight polysomnogram or with the battery of testing during the day
- •Consumption of more than 2 alcoholic beverages per day
- •Any illicit drug usage or marijuana usage more than once a week
- •Any individual in the household currently on CPAP or on CPAP in the past
- •A score of 26 or less on the Mini Mental State Examination (MMSE)
研究组 & 干预措施
Active CPAP
Active Continuous Positive Airway Pressure (CPAP)
干预措施: Active CPAP (Device)
Sham CPAP
Sham Continuous Positive Airway Pressure (CPAP)
干预措施: Sham CPAP (Device)
结局指标
主要结局
Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR
时间窗: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention
There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR)
Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD
时间窗: 2 months and 6 months post intervention
There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD) SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness).
Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL
时间窗: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention
There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL)
次要结局
- Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)(2 months and 6 months post intervention)
- Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS)(Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention)
- Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT)(2 months and 6 months post intervention)
- Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec)(2 months and 6 months post intervention)
- Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD)(2 months and 6 months post intervention)
- Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)(2 months and 6 months post intervention)
- Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS)(diagnostic visit (baseline))
- Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)(2 months and 6 months post intervention)
- Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)(2 months and 6 months post intervention)
- Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL)(Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention)
- Mood(Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention)
研究者
Clete A. Kushida
Principal Investigator
Stanford University