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Stress and Insomnia

Stress and Insomnia: Investigating a Bidirectional Relation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02591303
Acronym
StresSleep
Enrollment
15
Registered
2015-10-29
Start date
2015-11-03
Completion date
2016-09-15
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Stress

Keywords

Insomnia, Stress, Real-life stressful events

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.

Interventions

OTHERStress reactions measurement during stressful and neutral driving sessions

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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER
Labex Brain
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability at the stressful eventDay 19 after pre-inclusion
Skin conductance changes at the stressful eventDay 19 after pre-inclusionElectrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens
Reaction times at the stressful eventDay 19 after pre-inclusion

Secondary

MeasureTime frame
Total sleep time by polysomnographyDays 17, 18 and 19 after pre-inclusion
Rapid Eye Movement (REM) duration by polysomnographyDays 17, 18 and 19 after pre-inclusion
Non-Rapid Eye Movement (NREM) duration by polysomnographyDays 17, 18 and 19 after pre-inclusion
Sleep spindle density by polysomnographyDays 17, 18 and 19 after pre-inclusion
Total sleep time obtained by actimetryEvery night between pre-inclusion and Day 20 (study termination)
Sleep efficiency obtained by actimetryEvery night between pre-inclusion and Day 20 (study termination)
Wake after sleep onset obtained by actimetryEvery night between pre-inclusion and Day 20 (study termination)
Sleep latency obtained by actimetryEvery night between pre-inclusion and Day 20 (study termination)
Visual analogue scale for driving stressfulnessDays 17, 18 and 19 after pre-inclusion
Presleep State Arousal ScaleDays 10, 18, 19 and 20 after pre-inclusion
PostTraumatic Stress Disorder checklistDay 20

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026