CHU de Nimes
Nîmes, France
Location status: Recruiting
Location contact
Anissa Megzari
CONTACT
Anna Laura RASSU
SUB_INVESTIGATOR
Beatriz ABRIL
SUB_INVESTIGATOR
Caroline ALOVISETTI
SUB_INVESTIGATOR
Elisa EVANGELISTA
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06732284
The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood disorders or sleep inertia. Controls will be patients referred to the Sleep Disorders and Acupuncture Unit for polysomnography as part of the screening process for a sleep disorder. Only controls presenting an apnea-hypopnea index < 15/h, a periodic leg movements index during sleep < 15/h and a total sleep time ≥ 6 hours on the video-polysomnography will be analyzed.
Interested in participating?
Request Info18 year–54 year
All sexes
Observational
Nîmes, France
Location status: Recruiting
Anissa Megzari
CONTACT
Anna Laura RASSU
SUB_INVESTIGATOR
Beatriz ABRIL
SUB_INVESTIGATOR
Caroline ALOVISETTI
SUB_INVESTIGATOR
Elisa EVANGELISTA
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Five PVT tests (before sleep at 7pm, 7am, 7:30am, 8am and 11am). The PVT is a 10-minute test designed to assess the vigilance and sustained attention by measuring reaction times (RT) to visual stimuli. During the test, participants are required to monitor the computer screen and press the response button as soon as a millisecond counter appears which will stop the counter and display the RT in milliseconds. The stimuli are randomly presented.
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.
Time frame: Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am
Change in the number of omissions in the PVT test. An omission is defined as a reaction time (RT) ≥ 500 msec.
Time frame: Day 0
Measured by Idiopathic Hypersomnia Severity Scale (IHSS). Sleep inertia will be defined as severe in the case of a score ≥ 2 for both items 3 and 4 (frequent and lasting more than 30 min), absent in the case of a score = 0 for both items 3 and 4, and mild in the other cases.
Time frame: Day 0
Measured in years
Time frame: Day 0
Male/female
Time frame: Day 0
Kg/m2
Time frame: Day 0
Years
Time frame: Day 0
Measured by polysomnography, minutes
Time frame: Day 0
Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100]
Time frame: Day 0
Measured by polysomnography, minutes
Time frame: Day 0
Measured by polysomnography, percentage
Time frame: Day 0
Measured by polysomnography, minutes
Time frame: Day 0
Measured by polysomnography, number of microarousals /hour of sleep
Time frame: Day 0
Measured by polysomnography, number of apneas and hypopneas /hour of sleep
Time frame: Day 0
Measured by polysomnography, number of periodic leg movements /hour of sleep
Time frame: 7pm, 7am, 7:30am, 8am and 11am)
Karolinska Sleepiness Scale (KSS)
Time frame: Day 1
Epworth Sleepiness Scale (ESS)
Time frame: Day 1
Beck Depression Inventory (BDI-II)
Time frame: Day 1
Fatigue Severity Scale (FSS)
Time frame: Day 1
Hospital Anxiety Depression Scale (HADS)
Time frame: Day 1
Apathy Evaluation Scale
Time frame: Day 1
Insomnia Severity Index (ISI)
Time frame: Day 1
Horne and Ostberg Circadian Typology Questionnaire
Time frame: Day 1
Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable)
Time frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Time frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Time frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Time frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Time frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Time frame: Week 2
Measured via actimetry and sleep diary over a two-week period
Time frame: Week 2
Measured via actimetry and sleep diary over a two-week period
Time frame: Week 2
Measured via actimetry and sleep diary over a two-week period, minutes
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: IN-DEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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