Stress and Insomnia

Stress Clinical Trial

— StresSleep  

Official title:

Stress and Insomnia: Investigating a Bidirectional Relation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591303
• Other study ID #: CHUBX 2015/12
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: August 22, 2017
• Start date: November 3, 2015
• Est. completion date: September 15, 2016

Study information

• Verified date: August 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 15, 2016
• Est. primary completion date: September 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Stress

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Labex Brain

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability at the stressful event		Day 19 after pre-inclusion
Primary	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
Primary	Reaction times at the stressful event		Day 19 after pre-inclusion
Secondary	Total sleep time by polysomnography		Days 17, 18 and 19 after pre-inclusion
Secondary	Rapid Eye Movement (REM) duration by polysomnography		Days 17, 18 and 19 after pre-inclusion
Secondary	Non-Rapid Eye Movement (NREM) duration by polysomnography		Days 17, 18 and 19 after pre-inclusion
Secondary	Sleep spindle density by polysomnography		Days 17, 18 and 19 after pre-inclusion
Secondary	Total sleep time obtained by actimetry		Every night between pre-inclusion and Day 20 (study termination)
Secondary	Sleep efficiency obtained by actimetry		Every night between pre-inclusion and Day 20 (study termination)
Secondary	Wake after sleep onset obtained by actimetry		Every night between pre-inclusion and Day 20 (study termination)
Secondary	Sleep latency obtained by actimetry		Every night between pre-inclusion and Day 20 (study termination)
Secondary	Visual analogue scale for driving stressfulness		Days 17, 18 and 19 after pre-inclusion
Secondary	Presleep State Arousal Scale		Days 10, 18, 19 and 20 after pre-inclusion
Secondary	PostTraumatic Stress Disorder checklist		Day 20