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Completed

NCT Number: NCT02591303

Stress and Insomnia

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Heart rate variability at the stressful event

    Time frame: Day 19 after pre-inclusion

  2. Skin conductance changes at the stressful event

    Time frame: Day 19 after pre-inclusion

    Electrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens

  3. Reaction times at the stressful event

    Time frame: Day 19 after pre-inclusion

Secondary outcomes

  1. Total sleep time by polysomnography

    Time frame: Days 17, 18 and 19 after pre-inclusion

  2. Rapid Eye Movement (REM) duration by polysomnography

    Time frame: Days 17, 18 and 19 after pre-inclusion

  3. Non-Rapid Eye Movement (NREM) duration by polysomnography

    Time frame: Days 17, 18 and 19 after pre-inclusion

  4. Sleep spindle density by polysomnography

    Time frame: Days 17, 18 and 19 after pre-inclusion

  5. Total sleep time obtained by actimetry

    Time frame: Every night between pre-inclusion and Day 20 (study termination)

  6. Sleep efficiency obtained by actimetry

    Time frame: Every night between pre-inclusion and Day 20 (study termination)

  7. Wake after sleep onset obtained by actimetry

    Time frame: Every night between pre-inclusion and Day 20 (study termination)

  8. Sleep latency obtained by actimetry

    Time frame: Every night between pre-inclusion and Day 20 (study termination)

  9. Visual analogue scale for driving stressfulness

    Time frame: Days 17, 18 and 19 after pre-inclusion

  10. Presleep State Arousal Scale

    Time frame: Days 10, 18, 19 and 20 after pre-inclusion

  11. PostTraumatic Stress Disorder checklist

    Time frame: Day 20

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Labex Brain

Registry information

Official study title

Stress and Insomnia: Investigating a Bidirectional Relation

Acronym: StresSleep

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
May 14, 2026

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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