Stress and Insomnia (StresSleep)

Stress and Insomnia: Investigating a Bidirectional Relation

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.

Study Overview

• Status: Completed
• Conditions: Stress; Insomnia
• Intervention / Treatment: Other: Stress reactions measurement during stressful and neutral driving sessions

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insomnia group; 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	Other: Stress 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.
Experimental: Control group; No sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%)	Other: Stress 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Labex Brain

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2015
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): September 15, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimated): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Stress; Insomnia; Real-life stressful events
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: CHUBX 2015/12; 2015-A01287-42 (Other Identifier: ANSM)