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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01287-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Labex Brain | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insomnia group | Experimental | Patients with insomnia: sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning, objectified low sleep quality (Sleep Efficiency <85%) with 10 days actigraphy |
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| Control group | Experimental | No sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress reactions measurement during stressful and neutral driving sessions | Other | Stress effects will be measured during 3 driving sessions (training without events on Day 17, with neutral events on Day 18, with stressful events on Day19), through nighttime PSG and questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability at the stressful event | Day 19 after pre-inclusion | |
| Skin conductance changes at the stressful event | Electrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens | Day 19 after pre-inclusion |
| Reaction times at the stressful event | Day 19 after pre-inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time by polysomnography | Days 17, 18 and 19 after pre-inclusion | |
| Rapid Eye Movement (REM) duration by polysomnography | Days 17, 18 and 19 after pre-inclusion | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26866361 | Result | Altena E, Micoulaud-Franchi JA, Geoffroy PA, Sanz-Arigita E, Bioulac S, Philip P. The bidirectional relation between emotional reactivity and sleep: From disruption to recovery. Behav Neurosci. 2016 Jun;130(3):336-50. doi: 10.1037/bne0000128. Epub 2016 Feb 11. | |
| 29664207 | Result | Altena E, Daviaux Y, Sanz-Arigita E, Bonhomme E, de Sevin E, Micoulaud-Franchi JA, Bioulac S, Philip P. How sleep problems contribute to simulator sickness: Preliminary results from a realistic driving scenario. J Sleep Res. 2019 Apr;28(2):e12677. doi: 10.1111/jsr.12677. Epub 2018 Apr 17. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Non-Rapid Eye Movement (NREM) duration by polysomnography |
| Days 17, 18 and 19 after pre-inclusion |
| Sleep spindle density by polysomnography | Days 17, 18 and 19 after pre-inclusion |
| Total sleep time obtained by actimetry | Every night between pre-inclusion and Day 20 (study termination) |
| Sleep efficiency obtained by actimetry | Every night between pre-inclusion and Day 20 (study termination) |
| Wake after sleep onset obtained by actimetry | Every night between pre-inclusion and Day 20 (study termination) |
| Sleep latency obtained by actimetry | Every night between pre-inclusion and Day 20 (study termination) |
| Visual analogue scale for driving stressfulness | Days 17, 18 and 19 after pre-inclusion |
| Presleep State Arousal Scale | Days 10, 18, 19 and 20 after pre-inclusion |
| PostTraumatic Stress Disorder checklist | Day 20 |
| D001523 |
| Mental Disorders |