Clinical Trials

Twelve-week Study Of The Safety And Efficacy Of JZP-110 In The Treatment Of Excessive Sleepiness In OSA

Scottsdale/Phoenix, AZ

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Twelve-week Study Of The Safety And Efficacy Of JZP-110 In The Treatment Of Excessive Sleepiness In OSA

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information

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Site IRB:
15-003448
NCT ID:
NCT02348606
Sponsor Protocol Number:
14-003

Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

Scottsdale/Phoenix, AZ

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Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Determine 1) the magnitude of SMG and skin a-syn density change over time, 2) the

improvement in adequate tissue acquisition doing bilateral SMG biopsies, 3) any laterality differences between

SMG gland a-syn density, 4) correlate a-syn density and changes in density between SMG and skin biopsies

Specific Aim 1. Determine, with bilateral submandibular gland (SMG) biopsies in 30 clinically

diagnosed subjects with Parkinson’s disease (PD) and 20 clinically probable REM sleep behavior

disorder (RBD) subjects whether bilateral biopsies improve the rate of acquisition of adequate

glandular tissue, whether alpha-synuclein (a-syn) SMG pathology correlates with clinical severity

and/or disease duration, and whether there is a left-right difference in the density of a-syn pathology.

Specific Aim 2. Determine, with a second SMG biopsy in previously biopsied PD and RBD subjects,

whether a-syn pathology density increases, decreases, or remains the same after a 1.5-2 year time

interval and whether there is a correlation between a-syn SMG pathology and clinical and/or disease

progression.

Specific Aim 3. Determine whether a-syn pathology density in skin punch biopsies correlates

with clinical measures and increases, decreases, or remains the same after a 1.5-2 year time

interval, and whether the density and changes over time correlate with those found in SMG

biopsies.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information

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Site IRB:
21-007395

Physiologic Effects of Sleep Restriction

Rochester, MN

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Physiologic Effects of Sleep Restriction

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
11-002121
NCT ID:
NCT01433315
Sponsor Protocol Number:
11-002121

A Long-Term Safety Study Of JZP-110 In The Treatment Of Excessive Sleepiness In Subjects With Narcolepsy Or OSA

Scottsdale/Phoenix, AZ

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A Long-Term Safety Study Of JZP-110 In The Treatment Of Excessive Sleepiness In Subjects With Narcolepsy Or OSA

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
15-003449
NCT ID:
NCT02348632
Sponsor Protocol Number:
14-005

Open-label Study Of Nelotanserin In Lewy Body Dementia With Visual Hallucinations Or REM Sleep Behavior Disorder

Rochester, MN

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Open-label Study Of Nelotanserin In Lewy Body Dementia With Visual Hallucinations Or REM Sleep Behavior Disorder

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location

Status

Contact

Rochester, MN

Closed-enrolling by invitation

View complete study & contact information

Print study details

Site IRB:
16-006620
NCT ID:
NCT02871427
Sponsor Protocol Number:
RVT-102-2003

A 4-Week Study Of The Safety, Efficacy, And Pharmacokinetics Of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] In Subjects With Parkinson's Disease And Excessive Sleepiness

Scottsdale/Phoenix, AZ

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A 4-Week Study Of The Safety, Efficacy, And Pharmacokinetics Of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] In Subjects With Parkinson's Disease And Excessive Sleepiness

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
16-009688
NCT ID:
NCT03037203
Sponsor Protocol Number:
JZP166-201

HELP-HY: Health Education and sLeep Program in HYpertension

Rochester, MN

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HELP-HY: Health Education and sLeep Program in HYpertension

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed. In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (=6.5 hours/night).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
17-004044
NCT ID:
NCT03255746
Sponsor Protocol Number:
17-004044

A Study Of Sleep Health, Sleep Disorders, And Cognitive Functioning After Heart Transplantation

Scottsdale/Phoenix, AZ, Rochester, MN

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A Study Of Sleep Health, Sleep Disorders, And Cognitive Functioning After Heart Transplantation

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to investigate the relationships among sleep health characteristics, sleep disorders, and cognitive functioning after heart transplantation, which will critically inform the development of precision sleep health interventions to promote optimal cognitive functioning for this complex population.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Rochester, MN	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
24-013570

Non-Contact Point Of Care Device to Detect Signals During Sleep Studies

Scottsdale/Phoenix, AZ

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Non-Contact Point Of Care Device to Detect Signals During Sleep Studies

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The primary aim in Phase I of the study is to evaluate whether the proposed sensing technology was demonstrated to be exceptionally effective. In Phase II of the study, the following aims are proposed to mature the prototype hardware into a production ready system, to finalize processing software and develop interfaces for end users / clinicians, and to validate system performance against current state-of-the-art system in a human subject study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
21-008384

Evaluate Sleep Quality from Wearable Physiologic Monitor

Rochester, MN

See Details

Evaluate Sleep Quality from Wearable Physiologic Monitor

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to demonstrate proof-of-concept feasibility for Mayo OMNI physiologic monitor correlation with sleep-wake measures obtained from the current gold-standards of actigraphy and polysomnography.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
22-004369

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Search Results 21-30 of 55 for "sleep disorders"

Twelve-week Study Of The Safety And Efficacy Of JZP-110 In The Treatment Of Excessive Sleepiness In OSA

Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

Physiologic Effects of Sleep Restriction

A Long-Term Safety Study Of JZP-110 In The Treatment Of Excessive Sleepiness In Subjects With Narcolepsy Or OSA

Open-label Study Of Nelotanserin In Lewy Body Dementia With Visual Hallucinations Or REM Sleep Behavior Disorder

A 4-Week Study Of The Safety, Efficacy, And Pharmacokinetics Of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] In Subjects With Parkinson's Disease And Excessive Sleepiness

HELP-HY: Health Education and sLeep Program in HYpertension

A Study Of Sleep Health, Sleep Disorders, And Cognitive Functioning After Heart Transplantation

Non-Contact Point Of Care Device to Detect Signals During Sleep Studies

Evaluate Sleep Quality from Wearable Physiologic Monitor

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