NL-OMON50853已完成4 期
Solriamfetol*s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function. - JZP110-405
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age and Sex
- •1. Male or female between 18 (or the legal age of consent in the
- •jurisdiction in which the study takes place) and 65 years of age,
- •Type of Participant and Disease Characteristics
- •2. Diagnosis of OSA according to International Classification of Sleep
- •Disorders, Third Edition criteria.
- •3. Participant report (with clinician concurrence) of at least 1 of the
- •following primary OSA therapy criteria:
- •Consistent number of hours of primary PAP therapy use (with
- •downloadable history) for OSA on at least 5 nights/week for at least 1
- •month prior to Baseline (with or without prior OSA surgical
- •intervention), OR
- •No current use of PAP therapy for at least 1 month prior to Baseline
- •but a history of at least 1 month of attempting to use PAP as the primary
- •OSA therapy with at least 1 documented adjustment that was made in an
- •attempt to optimize the therapy (with or without prior OSA surgical
- •intervention), OR
- •History of a surgical intervention intended to treat OSA symptoms
- •(with or without current PAP use as primary OSA therapy).
- •4. The participant has an age-corrected scaled score <= 8 on the DSST
- •Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) at the
- •Screening visit.
- •5. British Columbia-Cognitive Complaints Inventory >= 9 at Screening and
- •6. Epworth Sleepiness Scale (ESS) score > 10 at Screening and Baseline.
- •7. Usual nightly total sleep time of >= 6 hours.
- •8. Body mass index from 18.5 to < 40 kg/m2.
- •Sex and Contraceptive/Barrier Requirements
- •9. Male and female Participants
- •a. Male participants:
- •Male participants are eligible to participate if they agree to the following
- •during the study intervention period and for at least 14 days after the
- •last dose of study intervention:
- •Refrain from donating sperm
- •PLUS, either:
- •Be abstinent from heterosexual intercourse as their preferred and
- •usual lifestyle (abstinent on a long-term and persistent basis) and agree
- •to remain abstinent
- •Must agree to use contraception/barrier as detailed below
- •Agree to use a male condom with female partner use of an additional
- •highly effective contraceptive method with a failure rate of < 1% per
- •year as described in Appendix 5 Contraceptive and Barrier Requirements
- •when having sexual intercourse with a women of childbearing potential
- •(WOCBP) who is not currently pregnant.
- •b. Female participants:
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and 1 of the following conditions applies:
- •* Is a woman of nonchildbearing potential (WONCBP) as defined in
- •Appendix 5 Contraceptive and Barrier Guidance
- •* Is a WOCBP and using a contraceptive method that is highly effective
- •(with a failure rate of < 1% per year), as described in 0 Contraceptive
- 另有 9 项未显示
排除标准
- •1. Female participants who are pregnant, nursing, or lactating.
- •2. Usual bedtime later than 1 AM (0100 hours).
- •3. Occupation requiring nighttime or variable shift work.
- •4. Unable to understand or perform DSST test per investigator's
- •6. Diagnosis of another sleep disorder (other than OSA) including:
- •circadian rhythm sleep disorders, narcolepsy, restless legs syndrome
- •determined by participant sleep history.
- •7. Presence of acutely unstable major depression or current major
- •depressive episode as based on the judgement of the investigator.
- •8. Participants with active clinically significant illness, including
- •endocrine, neoplastic, gastrointestinal, hematological, hepatic,
- •immunologic, metabolic, neurological, pulmonary, and/or renal disease,
- •and/or surgical history which could interfere with the study efficacy,
- •safety, conduct or the ability of the participant to complete the study
- •based on the judgement of the investigator, or place the participant at
- •risk during the trial or compromise the study objectives.
- •9. History or presence of any other clinically relevant medical,
- •behavioral, or psychiatric disorder other than OSA that is associated with
- •an impact on cognitive function; including history or presence of
- •neurodegenerative condition (eg, mild cognitive impairment due to
- •Alzheimer's), autism, vascular dementia, active suicidal ideation, that
- •could affect the safety of the participant or interfere with study efficacy,
- •safety, conduct or the ability of the participant to complete the trial
- •based on the judgment of the investigator.
- •10. History or presence of bipolar disorder, bipolar related disorders,
- •schizophrenia, schizophrenia spectrum disorders, or other psychotic
- •disorders according to Diagnostic and Statistical Manual of Mental
- •Disorders, Fifth Edition (DSM-5) criteria.
- •11. History of bariatric surgery within the past year or a history of any
- •gastric bypass procedure.
- •13. Presence of renal impairment or calculated creatinine clearance < 60
- •14. Clinically significant ECG abnormality in the opinion of the
- •investigator.
- •15. Presence of significant cardiovascular disease including but not
- •limited to: myocardial infarction within the past year, unstable angina
- •pectoris, symptomatic congestive heart failure (ACC/American Heart
- •Association stage C or D), revascularization procedures within the past
- •year, uncontrolled atrial fibrillation, ventricular cardiac arrhythmias
- •requiring automatic implantable cardioverter defibrillator or medication
- •therapy, uncontrolled hypertension (as defined by Centers for Disease
- •Control and Prevention), systolic blood pressure >= 155 mmHg or
- •diastolic blood pressure >= 95 mmHg (at Screening or Baseline), or any
- •history of cardiovascular disease or any significant cardiovascular
- •condition that in the investigator's opinion may jeopardize participant
- •safety in the study.
- •16. Laboratory value(s) outside the laboratory reference range that is
- •considered to be clinically significant by the investigator (clinical
- •chemistry, hematology, and urinalysis). NOTE: Screening labs may be
- •repeated once.
- •17. Hypothyroidism or hyperthyroidism, unless stabilized by appropriate
- 另有 3 项未显示
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