Clinical trial NCT02591303: Stress and Insomnia
Official title: Stress and Insomnia: Investigating a Bidirectional Relation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Stress
Keywords: Insomnia
Stress
Real-life stressful events
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Labex Brain
First posted: 2015-10-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Insomnia is characterized by rumination and worry over stressful events affecting nighttime sleep. Emotional reactions while stressful events are ongoing have not often been investigated in insomnia. In the current study stress reactions will be measured during a real-life simulation experiment with stressful events and investigate not only how previous sleep patterns affect emotional reactivity to the event but also how the emotional events affect sleep patterns the following night.

Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects of either neutral or stressful events during driving. Through questionaires and intake polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep medication use and alternative sleep disorders than insomnia. Stress levels will be measured through skin conductance and heart rate variability during events and through nighttime polysomnography (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime PSG.

Investigators hypothesize that subjects with insomnia, compared to subjects without sleep complaints, show stronger emotional reactions to stressful events and stronger effects of stress on sleep quality the following night. Results will facilitate a model for emotional reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption converting into chronic insomnia and aid in developing customized insomnia treatment.


Eligibility criteria: Inclusion Criteria:

* Insomnia group: patients with insomnia (DSM-V criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning
* Control group: no self-reported sleep problems
* 20-50 years old
* Female
* Having given written informed consent to participate in the research project
* Driving license

Exclusion Criteria:

* Night and shift-workers,
* Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder,
* For insomnia group: all sleep disorders other than persistent insomnia,
* For control group: all sleep disorders
* Progressive neurological diseases that include restless legs syndrome,
* Cardiovascular disease other than treated hypertension,
* Unstable respiratory or endocrinological diseases,
* Reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms,
* Drug addiction, alcohol addiction during the previous 6 months (smoking is allowed),
* Having undertaken trans-meridian travel (± 3H) in the previous 1 month,
* Pregnant or lactating women.
* Chronic pain.
* Having simulator-sickness during the first practice session
* Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
* A change in skin conductance of less than 0.05 microSiemens after an auditory stimulus.
* Left-handedness
* Patient participating to any other interventional study

Primary outcomes:
measure: Heart rate variability at the stressful event
timeFrame: Day 19 after pre-inclusion
measure: Skin conductance changes at the stressful event
timeFrame: Day 19 after pre-inclusion
measure: Reaction times at the stressful event
timeFrame: Day 19 after pre-inclusion
Secondary outcomes:
measure: Total sleep time by polysomnography
timeFrame: Days 17, 18 and 19 after pre-inclusion
measure: Rapid Eye Movement (REM) duration by polysomnography
timeFrame: Days 17, 18 and 19 after pre-inclusion
measure: Non-Rapid Eye Movement (NREM) duration by polysomnography
timeFrame: Days 17, 18 and 19 after pre-inclusion
measure: Sleep spindle density by polysomnography
timeFrame: Days 17, 18 and 19 after pre-inclusion
measure: Total sleep time obtained by actimetry
timeFrame: Every night between pre-inclusion and Day 20 (study termination)
measure: Sleep efficiency obtained by actimetry
timeFrame: Every night between pre-inclusion and Day 20 (study termination)
measure: Wake after sleep onset obtained by actimetry
timeFrame: Every night between pre-inclusion and Day 20 (study termination)
measure: Sleep latency obtained by actimetry
timeFrame: Every night between pre-inclusion and Day 20 (study termination)
measure: Visual analogue scale for driving stressfulness
timeFrame: Days 17, 18 and 19 after pre-inclusion
measure: Presleep State Arousal Scale
timeFrame: Days 10, 18, 19 and 20 after pre-inclusion
measure: PostTraumatic Stress Disorder checklist
timeFrame: Day 20
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: