InsomniaStresSleepNCT02591303
Stress and Insomnia
A study testing Stress reactions measurement during stressful and neutral driving sessions in people with Insomnia and Stress, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Stress reactions measurement during stressful and neutral driving sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2015to 15 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Stress reactions measurement during stressful and neutral driving sessions
- Keywords
- Insomnia, Stress, Real-life stressful events
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reactions measurement during stressful and neutral driving sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stress reactions measurement during stressful and neutral driving sessions |
| Control group | Experimental | No sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%) Receives: Other: Stress reactions measurement during stressful and neutral driving sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability at the stressful event
Measured: 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
Measured: Day 19 after pre-inclusion
Reaction times at the stressful event
Measured: Day 19 after pre-inclusion
Secondary outcomes (11)
Total sleep time by polysomnography
Measured: Days 17, 18 and 19 after pre-inclusion
Rapid Eye Movement (REM) duration by polysomnography
Measured: Days 17, 18 and 19 after pre-inclusion
Non-Rapid Eye Movement (NREM) duration by polysomnography
Measured: Days 17, 18 and 19 after pre-inclusion
Sleep spindle density by polysomnography
Measured: Days 17, 18 and 19 after pre-inclusion
Total sleep time obtained by actimetry
Measured: Every night between pre-inclusion and Day 20 (study termination)
Sleep efficiency obtained by actimetry
Measured: Every night between pre-inclusion and Day 20 (study termination)
Wake after sleep onset obtained by actimetry
Measured: Every night between pre-inclusion and Day 20 (study termination)
Sleep latency obtained by actimetry
Measured: Every night between pre-inclusion and Day 20 (study termination)
Visual analogue scale for driving stressfulness
Measured: Days 17, 18 and 19 after pre-inclusion
Presleep State Arousal Scale
Measured: Days 10, 18, 19 and 20 after pre-inclusion
PostTraumatic Stress Disorder checklist
Measured: Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start3 Nov 2015
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Labex Brain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591303
- Sponsor's protocol ID
- CHUBX 2015/12
- Other IDs
- 2015-A01287-42
- Acronym
- StresSleep
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26866361Altena 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.
PubMed 29664207
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Insomnia: Investigating a Bidirectional Relation
- ClinicalTrials.gov ID
- NCT02591303
- Acronym / sponsor ID
- StresSleep / CHUBX 2015/12
- Keywords
- Insomnia, Stress, Real-life stressful events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Labex Brain
- Study start
- 3 Nov 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia group | Experimental | Other: Stress reactions measurement during stressful and neutral driving sessionsPatients 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 |
| Control group | Experimental | Other: Stress reactions measurement during stressful and neutral driving sessionsNo sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress reactions measurement during stressful and neutral driving sessionsStress 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. | Other | Control group, Insomnia group |
Primary outcome
Heart rate variability at the stressful event
Time frame: Day 19 after pre-inclusion
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
Reaction times at the stressful event
Time frame: Day 19 after pre-inclusion
11 secondary outcomes
Total sleep time by polysomnography
Time frame: Days 17, 18 and 19 after pre-inclusion
Rapid Eye Movement (REM) duration by polysomnography
Time frame: Days 17, 18 and 19 after pre-inclusion
Non-Rapid Eye Movement (NREM) duration by polysomnography
Time frame: Days 17, 18 and 19 after pre-inclusion
Sleep spindle density by polysomnography
Time frame: Days 17, 18 and 19 after pre-inclusion
Total sleep time obtained by actimetry
Time frame: Every night between pre-inclusion and Day 20 (study termination)
Sleep efficiency obtained by actimetry
Time frame: Every night between pre-inclusion and Day 20 (study termination)
Wake after sleep onset obtained by actimetry
Time frame: Every night between pre-inclusion and Day 20 (study termination)
Sleep latency obtained by actimetry
Time frame: Every night between pre-inclusion and Day 20 (study termination)
Visual analogue scale for driving stressfulness
Time frame: Days 17, 18 and 19 after pre-inclusion
Presleep State Arousal Scale
Time frame: Days 10, 18, 19 and 20 after pre-inclusion
PostTraumatic Stress Disorder checklist
Time frame: Day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 26866361Altena 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.
- Results publication: PubMed 29664207Altena 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress reactions measurement during stressful and neutral driving sessions in people with Insomnia and Stress, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability at the stressful event (time frame: Day 19 after pre-inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.