Obstructive Sleep Apnea Syndrome

Home Respiratory Polygraphy

Standard Polysomnography

Hospital Clinic

Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.

Diagnosis, Cost and Therapeutic Decision-Making of Home Respiratory Polygraphy for Patients Without High Suspicion of OSA or With Comorbidity - Hospital Polysomnography in Comparison With Three Nights of Home Respiratory Polygraphy

The investigators want to compare the clinical decision between full PSG (CPAP or NO CPAP)and respiratory polygraphy performed during 3 nights (CPAP or NO CPAP) when there is discrepancy between symptoms and data from respiratory polygraphy.

AHI obtained from full PSG versus the mean values of the 3 respiratory polygraphy nights

Cost-effectiveness of the 2 different patients' management methods

Jose M. Montserrat

MD PhD. Pulmonary

Hospital Clinic of Barcelona

Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid

Lacosamide

Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.

Sugar Pill

Total

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Scale 0 - 24 Higher scores indicate more severe symptoms

Change in Epworth Sleepiness Scale Score From Baseline to Visit 4

Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.

Change in the Fatigue Severity Scale From Baseline to Visit 4.

Range 0-21, where higher scores more impairment (in terms of sleep quality).

Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4

Range 0-20 where lower scores indicate more impairment (sleep related QOL).

Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.

Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.

Change in Adverse Event Profile (AEP) From Baseline to Visit 4.

Range 0-27, where higher scores indicate more impairment (depressive symptoms)

Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.

Change in Daily Seizure Frequency From Baseline to Visit 4

Range 0 -10 where higher scores reflect better quality of life.

Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4

Overall Study

Nancy Foldvary-Schaefer, DO, MS

Partial Epilepsy

Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid

Placebo will be packaged identically to experimental drug and titrated according to the same schedule.

Placebo

Cleveland Clinic

Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

Searching for "Sleep Friendly" Therapies for a Sleepy Population: A Double-Blind, Placebo-Controlled, Randomized Trial to Assess the Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

narcolepsy/− nicotine

Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.

Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

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