Clinical Trials

A Study To Assess The Efficacy And Safety Of AXS-12 (Reboxetine) In Patients With Narcolepsy

Scottsdale/Phoenix, AZ

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A Study To Assess The Efficacy And Safety Of AXS-12 (Reboxetine) In Patients With Narcolepsy

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

The purpose of this study is to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

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:
21-010566
NCT ID:
NCT05059223

A Study Of TAK-861 For The Treatment Of Selected Central Hypersomnia Conditions

Scottsdale/Phoenix, AZ

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A Study Of TAK-861 For The Treatment Of Selected Central Hypersomnia Conditions

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:
2/3
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

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

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:
24-012038
NCT ID:
NCT05816382
Sponsor Protocol Number:
TAK-861-2003

Study Evaluating Nelotanserin For Treatment Of REM Sleep Behavior Disorder In Subjects With Dementia (DLB Or PDD)

Rochester, MN

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Study Evaluating Nelotanserin For Treatment Of REM Sleep Behavior Disorder In Subjects With Dementia (DLB Or PDD)

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 safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

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:
16-008523
NCT ID:
NCT02708186
Sponsor Protocol Number:
RVT-102-2002

Sleep For Stroke Management And Recovery Trial

Jacksonville, FL

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Sleep For Stroke Management And Recovery Trial

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

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

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Site IRB:
19-011312
NCT ID:
NCT03812653

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

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

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

A Study to Determine If Use of An Educational Video Simulating Common CPAP-Related Problems Will Increase Compliance Among New CPAP Users

Jacksonville, FL

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A Study to Determine If Use of An Educational Video Simulating Common CPAP-Related Problems Will Increase Compliance Among New CPAP Users

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

The purpose of this study is to determine if use of an educational video simulating common CPAP-related problems will increase compliance among new CPAP users.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
18-000955
Sponsor Protocol Number:
18-000955

Efficacy of Extended Melatonin on sleep cycle in patients with PD and RBD.

Jacksonville, FL

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Efficacy of Extended Melatonin on sleep cycle in patients with PD and RBD.

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

The primary aim of this study is to compare effectiveness of immediate versus extended-release melatonin as a supplement affecting the sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ). The secondary aim is to evaluate the superiority and effect of immediate and extended-release melatonin versus not taking any melatonin on sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).

Rapid eye movement (REM) sleep behavior disorder (RBD) is very common in patients with Parkinson disease and manifests with the loss of REM sleep atony, vigorous motor jerks, nocturnal vocalizations and dream enactment. Melatonin is commonly used as symptomatic management for RBD, but its efficacy is only supported by observational studies and a few controlled trials with relatively small number of participants. Melatonin may influence sleep cycle and affect clinical manifestations of RBD by decreasing muscle tonicity during REM sleep.

Sleep normally cycles through REM and non-rapid eye movement (NREM) stages on average 4 to 6 times during the night. As the night progresses, fewer NREM stages occur, and the duration of REM sleep episodes increases. In a US-based randomized, crossover pharmacokinetic (PK) evaluation study, an extended-release melatonin (ERM) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the immediate- release melatonin (IRM). We hypothesize that extended-release melatonin would be more helpful in regulating sleep cycle and affecting RBD, since REM density increases as night progresses. To our knowledge, no study that compares the efficacy of extended versus immediate-release melatonin on sleep cycle and its effect on RBD in patients with Parkinson disease has been done.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
21-003326
NCT ID:
NCT05307770

A Study To Evaluate Sleep For Stroke Management And Recovery

Rochester, MN

See Details

A Study To Evaluate Sleep For Stroke Management And Recovery

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

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

Print study details

Site IRB:
19-002553
NCT ID:
NCT03812653
Sponsor Protocol Number:
HUM00147316

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

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Search Results 21-30 of 489 for sleep

A Study To Assess The Efficacy And Safety Of AXS-12 (Reboxetine) In Patients With Narcolepsy

A Study Of TAK-861 For The Treatment Of Selected Central Hypersomnia Conditions

Study Evaluating Nelotanserin For Treatment Of REM Sleep Behavior Disorder In Subjects With Dementia (DLB Or PDD)

Sleep For Stroke Management And Recovery Trial

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

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

A Study to Determine If Use of An Educational Video Simulating Common CPAP-Related Problems Will Increase Compliance Among New CPAP Users

Efficacy of Extended Melatonin on sleep cycle in patients with PD and RBD.

A Study To Evaluate Sleep For Stroke Management And Recovery

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

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