Measurement of Sleep-Onset REM Episodes During Sleep With and Without Sleep Deprivation - SOREM Episodes: State or Trait?
Descrizione riassuntiva dello studio
Approximately 5% of the general population suffers from central hypersomnolence disorders. This group of diseases includes various clinical pictures, such as narcolepsy type 1 (NT1) and type 2 (NT2), idiopathic hypersomnia (IH), and non-organic hypersomnias, among others. The common main symptom is excessive daytime sleepiness and/or increased sleep duration, with NT1 additionally characterized by cataplexy. Cataplexy is a temporary loss of muscle tone triggered by emotional situations. For the diagnosis of hypersomnolence, standardized nocturnal sleep studies (polysomnography; PSG) and daytime tests (multiple sleep latency test; MSLT) are conducted to obtain objective measurements. The key measurements are the time to sleep onset and the number of early REM sleep (=dream sleep) episodes, also called sleep onset REM (SOREM) episodes. The problem with current diagnostics is the unreliable test results of the MSLT test. Upon repetition of the MSLT, the same patient unexpectedly exhibited either more or fewer SOREM episodes, leading to a change in diagnosis in about 50% of patients. In our research project, we aim to find out whether an improved version of the MSLT test provides more reliable results and thus can improve diagnostics. An essential influencing factor on SOREM episodes seems to be the preceding sleep duration and body temperature. This work therefore investigates the occurrence of SOREM episodes depending on sleep duration and body temperature. To this end, a partial or total sleep deprivation is applied, and the number of SOREM episodes is measured in three hypersomnia groups. Using continuous temperature measurements, we investigate whether sleep deprivation is associated with a change in body temperature.
(BASEC)
Intervento studiato
With the study, we aim to improve the reliability of the MSLT test for the diagnosis of hypersomnolence. To do this, we need to understand what determines the occurrence of SOREM episodes. So far, we know that narcolepsy patients form REM sleep (=dream sleep) very quickly and easily, but we still understand too little about which factors influence the occurrence of REM sleep. Recent studies in animals indicate that a change in external temperature strongly influences the tendency to REM sleep. Earlier observations showed that REM sleep also depends on sleep duration. For this reason, the study seeks to determine whether experimentally induced sleep deprivation promotes the tendency for REM sleep and whether this is associated with a change in body temperature. We suspect that sleep deprivation especially promotes the tendency for REM sleep and thus the number of SOREM episodes in narcolepsy patients, while this does not occur in patients with other hypersomnolences. In scientific language, the planned experimental sleep deprivation is referred to as intervention. The intervention is randomized, meaning that patients are randomly assigned to one of three groups of experimental sleep deprivation. Patients must then stay awake either during the first half of the night, the second half of the night, or the entire night. Additionally, the study examines using two tests (watching funny videos and a children's game
(BASEC)
Malattie studiate
Narcolepsy type 1 (NT1), Narcolepsy type 2 (NT2), hypersomnolence of other causes (idiopathic hypersomnia, insufficient sleep syndrome, sleep apnea syndrome, etc.)
(BASEC)
• Patients with hypersomnolence (daytime sleepiness with Epworth Sleepiness Scale (ESS) >10/24 points or hypersomnia with sleep duration >11 hours) • At least 1 SOREM episode in previous routine MSLT and/or in routine PSG at time of diagnosis. • The patients must be at least 18 years old and no more than 80 years old (BASEC)
Criteri di esclusione
• Pregnant or breastfeeding women • Medication treatment with sodium oxybate • Other diseases outside of hypersomnolence, considered for clinical reasons as causes of sleepiness and SOREMs (e.g., medications) (BASEC)
Luogo dello studio
Altro
(BASEC)
Barmelweid
(BASEC)
Sponsor
Klinik Barmelweid
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Ramin Khatami
+41 62 857 22 22
ramin.khatami@clutterbarmelweid.chKlinik Barmelweid
(BASEC)
Informazioni scientifiche
Klinik Barmelweid
+41 62 857 22 22
ramin.khatami@clutterbarmelweid.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
22.08.2022
(BASEC)
ID di studio ICTRP
DRKS00029645 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Messung der Sleep-Onset-REM Episoden während des Schlafes mit und ohne Schlafentzug- «SOREM Episodes: state or trait?» (BASEC)
Titolo accademico
Measurement of sleep-onset REM episodes during sleep with and without sleep deprivation- SOREM Episodes: state or trait? - MSLT_pro Study (ICTRP)
Titolo pubblico
Measurement of sleep-onset REM episodes during sleep with and without sleep deprivation- SOREM Episodes: state or trait? (ICTRP)
Malattie studiate
G47.4
G47Narcolepsy and cataplexySleep disordersG47.4 (ICTRP)
Intervento studiato
Group 1: Total sleep deprivation
Group 2: First half night sleep deprivation
Group 3: Second half night sleep deprivation (ICTRP)
Tipo di studio
interventional (ICTRP)
Disegno dello studio
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: diagnostic (ICTRP)
Criteri di inclusione/esclusione
Inclusion criteria: Subjective symptoms of daytime sleepiness (definition see below)
Epworth Sleepiness Scale (ESS) >10/24 points
At least 1 SOREM episode in previous routine MSLT and/or in routine PSG at time of diagnosis.
The patients must be at least 18 years old and no more than 80 years old
Ability and consent to electrophysiological testing
Ability to give informed consent (ICTRP)
Exclusion criteria: Pregnant or breastfeeding women
Drug therapy with sodium oxybate
Inability to follow the instructions on the study procedures due to language problems, mental disorders, dementia, etc.
Presence of comorbid diseases that make sleep deprivation impossible (e.g. epilepsy)
Evidence of accidentally found epilepsy-typical potentials in the baseline night investigation that make sleep deprivation impossible
The following diseases/conditions considered to cause hypersomnolence and SOREMs on clinical grounds:
o Other neurological disorders (e.g. stroke, multiple sclerosis, Parkinson's disease, severe traumatic brain injury, epilepsy)
o Unstable psychiatric disorders (including acute psychoses, acute suicidality, severe depression, drug abuse)
o Active infectious disease (e.g. encephalitis)
Endpoint primari e secondari
The aim of the study is to gain new insights into the clinical picture of narcolepsy and other diseases from the group of central hypersomnolence (narcolepsy, idiopathic hypersomnia, non-organic hypersomnia, chronic sleep deficiency syndrome, sleep apnea). The study can improve the diagnosis and classification of these diseases. New objective measurements are to be obtained that will enable simpler, faster and more precise diagnosis. New treatment options for drugs may also be derived from this. (ICTRP)
non disponibile
Data di registrazione
23.08.2022 (ICTRP)
Inclusione del primo partecipante
01.09.2022 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Ramin Khatami, ramin.khatami@barmelweid.ch, +41 62 857 22 22, Klinik Barmelweid (ICTRP)
ID secondari
2021-02265 (ICTRP)
Risultati-Dati individuali dei partecipanti
YesIndividual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), can be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to ramin.khatami@barmelweid.ch. To gain access, data requestors will need to sign a data access agreement. (ICTRP)
Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00029645 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile