Stress and Insomnia

Not Applicable

Completed

• Conditions: Stress; Insomnia

• Registration Number: NCT02591303
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2015-11-03
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate variability at the stressful event	Day 19 after pre-inclusion
Reaction times at the stressful event	Day 19 after pre-inclusion
Skin conductance changes at the stressful event	Day 19 after pre-inclusion	Electrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens

Secondary Outcome Measures

Name	Time	Method
Presleep State Arousal Scale	Days 10, 18, 19 and 20 after pre-inclusion
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
PostTraumatic Stress Disorder checklist	Day 20
Rapid Eye Movement (REM) duration by polysomnography	Days 17, 18 and 19 after pre-inclusion
Total sleep time 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)
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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France