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Treatment of Central Sleep Apnea Syndrome with low-pressure nasal continuous positive airway pressure and rebreathing.

Primary objective:To show that addition of dead space to low-pressure nCPAP (which is usually not effective but can be relatively well tolerated) makes the therapy effective and diminishes the apnea hypopnea index with >10/hour in patients…

Mapping for Acute Transvenous Phrenc nerve Stimulation Study

Protocol page 17The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins.

AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS

FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy (excessive…

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Investigating bedtime procrastination and circadian phase in patients with delayed sleep phase disorder

The current research is set to provide insight into the phenotypic characteristics of DSPD patients in terms of psychological characteristics, occurrence of co-morbidities, and behavioural characteristics such as bedtime routines and lifestyle, and…

The effects of ceasing opioid, benzodiazepine, or Z-hypnotic drug use on measures of driving performance and postural balance.

The aim of this study is primarily to investigate the effects of a withdrawal intervention on measures of driving performance in a clinical population that uses benzodiazepines, Z-hypnotics, or opioid analgesics chronically. As a secondary objective…

Sleep and biorhythm in ICU patients: a pilot study

To investigate the incidence and severity of disturbed biorhythm among ICU patients, and the effect on quality of sleep. We also aim to validate the novel ICU Depth Of Sleep (IDOS) index in detecting depth of sleep over time. Secondarily: we will…

A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERS

FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…

An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

During the study, an oral solution of JZP-507 produced on a commercial scale will be compared with a JZP-507 oral solution produced on a pilot scale (an oral solution of JZP-507 which is manufactured locally at PRA). The purpose of the study is to…

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of FT218 (batch A and batch B) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

Validation of the Sustained Attention to Response Task (SART) for assessing the fitness to drive in narcolepsy and idiopathic hypersomnia patients

Primary aim is to validate the SART as a screenings instrument for driver fitness in patients with narcolepsy and idiopathic hypersomnia.

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, ParallelGroup, Multicenter Study of the Safety and Efficacy of JZP 110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA)

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.

A double-blind, randomized study to evaluate plasma prolactin levels in healthy volunteers after single oral doses of lorazepam

Evaluation of the effect of single oral doses of lorazepam on plasma concentration of prolactin

Behavioral and psychological characteristics of children with narcolepsy

With this study we aim to investigate the emotional development, behavior, social behavior, variation in personality traits and intellectual functioning in a group of children who are diagnosed with narcolepsy with of without cataplexie, according…

What keeps the brain alert? - A magnetic resonance study into the neural correlates of vigilance in narcolepsy patients

No studies have yet investigated brain activity in NC patients in relation to alertness and sleep resistance. The aim of the current study is to obtain more insight into the regulatory mechanisms controlling alertness and sleep resistance in…

Voluntary motor activity in Restless Legs Syndrome and Periodic Limb Movements in Sleep

The aim of this study is to investigate the differences between RLS and PLMS.

A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects

The key objective of this study is to assess next-day residual effects of MK-4305 (20 and 40 mg) via driving performance after 1 day of dosing and after 8 days of dosing.

Double-blind, placebo- and active-controlled, randomized, single-ascending dose study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-462206 in healthy male subjects

- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…

Validation of the Actiwatch for older people with intellectual disability; a feasibility study

The first objective of this study is to investigate the feasibility of performing home sleep EEG registrations in older people with intellectual disability. The second objective of this study is the determine which sensitivity setting of the Sleep…

Sleep State Misperception Mispercieved?

We aim to establish whether our judgment of *misperception* is really doing justice to the condition paradoxical insomniacs suffer from. We should keep in mind that our present definition of sleep, based on the standardized polysomnographic scoring…