Insomnia Type; Sleep DisorderNCT03727906
Sleep and Cardiovascular Health in Adolescence
A study testing No pre-sleep arousal manipulation, pre-sleep arousal down-regulation and pre-sleep arousal up-regulation in people with Insomnia Type; Sleep Disorder, run by SRI International at 1 site in United States.
Trial summary
Insomnia is a prevalent and under-recognized disorder in adolescence, particularly in girls, with long-term repercussions for mental and physical health. This study assesses manifestation of autonomic hyperarousal and vulnerability to insomnia using a sample of male and female adolescents with and without Diagnostic… Read more about this study
- Who is it for?
- Ages 16 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Type; Sleep Disorder
- What is being tested?
- No pre-sleep arousal manipulation, pre-sleep arousal down-regulation and pre-sleep arousal up-regulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 27 Aug 2022
- 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 16 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be post-pubertal
- BMI <30 kg/m-2 to reduce the likelihood of obesity-related sleep-disordered breathing
Who cannot join
- Current use of drugs known to affect sleep and CV systems (e.g., Antidepressants, stimulants, beta-blockers)
- Serious history of, or current medical conditions that could affect brain function, or study participation, including Diabetes, cancer, neurological diseases (e.g., Seizure disorders) recurrent migraine, cardiovascular diseases (e.g., Hypertension) and traumatic brain injury with loss of consciousness >30 minutes
- Current DSM-5 diagnosis of Neurodevelopmental Disorders (e.g., Attention-Deficit/Hyperactivity Disorder)
- Current DSM-5 diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders
- Current DSM-5 diagnosis of Depressive and Anxiety Disorders (e.g., Major Depressive Disorder)
- Current DSM-5 diagnosis of Post-Traumatic Stress Disorder
Show all 13Show fewer
- Current DSM-5 diagnosis of Substance-Related and Addictive Disorders (e.g., Alcohol Use Disorder)
- History of and persistence in severe learning disorder, pervasive developmental disorder, or other condition requiring repeated or persistent specialized education (e.g., Estimated intellectual quotient (IQ) >2 standard deviations below mean)
- Current psychiatric disorders in both control and insomnia groups is exclusionary
- Past history of psychiatric disorders in controls is exclusionary (past history of psychiatric disorders in the insomnia group is not exclusionary)
- Shift work in the previous year and no time-zone travel in the past month
- Evidence of other DSM-5 Sleep-Wake Disorders (e.g., Narcolepsy), Breathing-Related Sleep Disorders (e.g., Obstructive Sleep Apnea Hypopnea, Circadian Rhythm Sleep-Wake Disorders and particularly Delayed Sleep Phase Type), and Parasomnias (e.g., Non-Rapid Eye Movement Sleep Arousal Disorders, Rapid Eye Movement Sleep Behavior Disorder and Restless Legs Syndrome)
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Insomnia is a prevalent and under-recognized disorder in adolescence, particularly in girls, with long-term repercussions for mental and physical health. This study assesses manifestation of autonomic hyperarousal and vulnerability to insomnia using a sample of male and female adolescents with and without Diagnostic and Statistical Manual (DSM-5) Insomnia Disorder. Outcomes from this study have the potential to inform prevention and treatment interventions for insomnia that can be implemented at a young age before chronic negative sequelae of this common disorder manifest.
Read the detailed description
Insomnia is highly prevalent in adolescence, particularly in post-pubertal girls and tends to persist over time. Insomnia is considered a hyperarousal disorder, in which abnormally elevated levels of cognitive and physiological activation, particularly evident at bed-time, prevent individuals from falling asleep and having a restorative night's sleep. Hyperarousal is a major pathophysiological mechanism linking insomnia with poor mental and physical health, including cardiovascular (CV) disease. The investigators and others have shown evidence of autonomic nervous system (ANS) dysfunction such as hyperactivation of the sympathetic branch of the ANS - a major etiological factor in CV disease - in young and midlife adults, both before and during sleep. It is unknown if ANS hyperarousal is evident in adolescents with insomnia.
The biological basis for an emerging sex difference in insomnia prevalence in adolescence is unknown. The investigators' pilot data reveal intriguing evidence of sex-differences in basic and stress-dependent ANS modulation during sleep in adolescents with girls showing a greater ANS response to stress. These data suggest the existence of a predisposing and stress-dependent ANS vulnerability in female adolescents, a potential pathway to develop insomnia. This study takes a novel approach to investigating the manifestation of physiological ANS and CV hyperarousal in adolescents with insomnia by experimentally manipulating the pre-sleep arousal state via stress-induced ANS up-regulation and relaxation-driven ANS down-regulation. In addition, the study focuses on sex differences in ANS and CV responses to pre-sleep ANS manipulation, potentially addressing the question of why female sex is a major risk factor for insomnia.
The investigators aim to test 110 male and female high-school students (16-20y) with and without DSM-5 Insomnia Disorder, during a regular in-lab polysomnographic night (baseline) and under experimental pre-sleep stress (psychosocial stressor) and pre-sleep relaxation (Virtual reality ANS bio-feedback) intervention nights, using state-of-the-art, noninvasive, beat-to-beat ANS and CV measures, including blood pressure, to assess nocturnal ANS and CV function in adolescents with insomnia (Aim 1); the impact of pre-sleep ANS arousal levels on nocturnal ANS and CV function, and sleep in adolescents with and without insomnia, considering possible sex differences (Aim 2), and the extent to which nocturnal ANS and CV function mediate the effect of pre-sleep arousal levels on objective and perceived sleep quality (Aim 3).
This study has the potential to elucidate pathophysiological ANS hyperarousal underlying Insomnia Disorder in adolescence, including potential reasons for the vulnerability to insomnia in girls, leading to better recognition and potentially new treatment strategies of this disorder targeted at the state of ANS hyperarousal in the pre-sleep period.
- Conditions
- Insomnia Type; Sleep Disorder
- Being tested
- No pre-sleep arousal manipulation, pre-sleep arousal down-regulation, pre-sleep arousal up-regulation
- Keywords
- Cardiovascular, Blood Pressure, ECG, EEG
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No pre-sleep arousal manipulationOther
Also called Baseline
As with the pre-sleep arousal up- and down-regulation nights, the participant will sleep in comfortable sound-proof and temperature-controlled bedroom and will go to bed and wake up at his/her self-reported usual school-week times. On this night, pre-sleep activities include watching television or reading a book.
pre-sleep arousal down-regulationOther
Also called pre-sleep relaxation
On the "low pre-sleep arousal night", about 30 min before lights-out, a 20 min session of relaxation-driven Virtual Reality (VR) + slow breathing will be conducted. Adolescents will be instructed to perform slow diaphragmatic breathing and to let the VR immersion guide them through this relaxation process.
pre-sleep arousal up-regulationOther
Also called pre-sleep stress
On the "high pre-sleep arousal" night, an anticipatory stress procedure from the Trier Social Stress Test (TSST) will be used to elicit stress-induced ANS activation in the pre-sleep period. About 30 min before lights-out participants will be told that the following morning they will need to prepare and give a 5-min speech in front of a panel of assessors who will judge their performance and ask questions. Participants will be shown the testing room (set up with chairs, video camera, microphone).
| Study group | Role | What they receive |
|---|---|---|
| Non-insomnia Group | Other | Non-insomnia participants will not meet criteria for current DSM-5 Insomnia Disorder or have a past history of insomnia.
Interventions (order is randomly assigned):
1. no pre-sleep arousal manipulation night;
2. pre-sleep arousal down-regulation night
3. pre-sleep arousal up-regulation night. Receives: Other: No pre-sleep arousal manipulation; Other: pre-sleep arousal down-regulation; Other: pre-sleep arousal up-regulation |
| Insomnia Group | Other | Insomnia Group participants will have to meet DSM-5 criteria for current Insomnia Disorder.
Interventions (order is randomly assigned):
1. no pre-sleep arousal manipulation night;
2. pre-sleep arousal down-regulation night
3. pre-sleep arousal up-regulation night. Receives: Other: No pre-sleep arousal manipulation; Other: pre-sleep arousal down-regulation; Other: pre-sleep arousal up-regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average nocturnal heart rate (HR), as a measure of cardiac contractility
Heart rate (HR) response to experimental manipulation
Measured: Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
Average nocturnal Pre-ejection period (PEP), as a measure of cardiac sympathetic activity
Pre-ejection period (PEP) response to experimental manipulation
Measured: Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start7 Jan 2019
- Primary completion30 Jun 2021
- Study completion27 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Type; Sleep DisorderStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- The experimental paradigm will consist of three in-lab counterbalanced non-consecutive (≥2 days in-between) polysomnography (PSG) nights in which we will modulate the level of pre-sleep psychophysiological arousal in a group of insomnia and non-insomnia adolescents. 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night (pre-sleep relaxation-driven Virtual reality ANS downregulation); 3. pre-sleep arousal up-regulation night (pre-sleep anticipation of stress using the Trier Social StressTest).
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Massimiliano de Zambotti, SRI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727906
- Sponsor's protocol ID
- 50116
- Status last verified
- Apr 2023
- First submitted
- 25 Oct 2018
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Cardiovascular Health in Adolescence
- ClinicalTrials.gov ID
- NCT03727906
- Acronym / sponsor ID
- 50116
- Conditions
- Insomnia Type; Sleep Disorder
- Keywords
- Cardiovascular, Blood Pressure, ECG, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 27 Aug 2022 (actual)
- First posted
- 1 Nov 2018 (actual)
- 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 a prevalent and under-recognized disorder in adolescence, particularly in girls, with long-term repercussions for mental and physical health. This study assesses manifestation of autonomic hyperarousal and vulnerability to insomnia using a sample of male and female adolescents with and without Diagnostic and Statistical Manual (DSM-5) Insomnia Disorder. Outcomes from this study have the potential to inform prevention and treatment interventions for insomnia that can be implemented at a young age before chronic negative sequelae of this common disorder manifest.
Detailed description
Insomnia is highly prevalent in adolescence, particularly in post-pubertal girls and tends to persist over time. Insomnia is considered a hyperarousal disorder, in which abnormally elevated levels of cognitive and physiological activation, particularly evident at bed-time, prevent individuals from falling asleep and having a restorative night's sleep. Hyperarousal is a major pathophysiological mechanism linking insomnia with poor mental and physical health, including cardiovascular (CV) disease. The investigators and others have shown evidence of autonomic nervous system (ANS) dysfunction such as hyperactivation of the sympathetic branch of the ANS - a major etiological factor in CV disease - in young and midlife adults, both before and during sleep. It is unknown if ANS hyperarousal is evident in adolescents with insomnia.
The biological basis for an emerging sex difference in insomnia prevalence in adolescence is unknown. The investigators' pilot data reveal intriguing evidence of sex-differences in basic and stress-dependent ANS modulation during sleep in adolescents with girls showing a greater ANS response to stress. These data suggest the existence of a predisposing and stress-dependent ANS vulnerability in female adolescents, a potential pathway to develop insomnia. This study takes a novel approach to investigating the manifestation of physiological ANS and CV hyperarousal in adolescents with insomnia by experimentally manipulating the pre-sleep arousal state via stress-induced ANS up-regulation and relaxation-driven ANS down-regulation. In addition, the study focuses on sex differences in ANS and CV responses to pre-sleep ANS manipulation, potentially addressing the question of why female sex is a major risk factor for insomnia.
The investigators aim to test 110 male and female high-school students (16-20y) with and without DSM-5 Insomnia Disorder, during a regular in-lab polysomnographic night (baseline) and under experimental pre-sleep stress (psychosocial stressor) and pre-sleep relaxation (Virtual reality ANS bio-feedback) intervention nights, using state-of-the-art, noninvasive, beat-to-beat ANS and CV measures, including blood pressure, to assess nocturnal ANS and CV function in adolescents with insomnia (Aim 1); the impact of pre-sleep ANS arousal levels on nocturnal ANS and CV function, and sleep in adolescents with and without insomnia, considering possible sex differences (Aim 2), and the extent to which nocturnal ANS and CV function mediate the effect of pre-sleep arousal levels on objective and perceived sleep quality (Aim 3).
This study has the potential to elucidate pathophysiological ANS hyperarousal underlying Insomnia Disorder in adolescence, including potential reasons for the vulnerability to insomnia in girls, leading to better recognition and potentially new treatment strategies of this disorder targeted at the state of ANS hyperarousal in the pre-sleep period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental paradigm will consist of three in-lab counterbalanced non-consecutive (≥2 days in-between) polysomnography (PSG) nights in which we will modulate the level of pre-sleep psychophysiological arousal in a group of insomnia and non-insomnia adolescents. 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night (pre-sleep relaxation-driven Virtual reality ANS downregulation); 3. pre-sleep arousal up-regulation night (pre-sleep anticipation of stress using the Trier Social StressTest).
| Arm | Type | Receives |
|---|---|---|
| Non-insomnia Group | Other | Other: No pre-sleep arousal manipulation, Other: pre-sleep arousal down-regulation, Other: pre-sleep arousal up-regulationNon-insomnia participants will not meet criteria for current DSM-5 Insomnia Disorder or have a past history of insomnia. Interventions (order is randomly assigned): 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night 3. pre-sleep arousal up-regulation night. |
| Insomnia Group | Other | Other: No pre-sleep arousal manipulation, Other: pre-sleep arousal down-regulation, Other: pre-sleep arousal up-regulationInsomnia Group participants will have to meet DSM-5 criteria for current Insomnia Disorder. Interventions (order is randomly assigned): 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night 3. pre-sleep arousal up-regulation night. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Must be post-pubertal
- BMI <30 kg/m-2 to reduce the likelihood of obesity-related sleep-disordered breathing
Key exclusion criteria (13 listed)
- Current use of drugs known to affect sleep and CV systems (e.g., Antidepressants, stimulants, beta-blockers)
- Serious history of, or current medical conditions that could affect brain function, or study participation, including Diabetes, cancer, neurological diseases (e.g., Seizure disorders) recurrent migraine, cardiovascular diseases (e.g., Hypertension) and traumatic brain injury with loss of consciousness >30 minutes
- Current DSM-5 diagnosis of Neurodevelopmental Disorders (e.g., Attention-Deficit/Hyperactivity Disorder)
- Current DSM-5 diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders
- Current DSM-5 diagnosis of Depressive and Anxiety Disorders (e.g., Major Depressive Disorder)
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 |
|---|---|---|
| No pre-sleep arousal manipulationAlso: BaselineAs with the pre-sleep arousal up- and down-regulation nights, the participant will sleep in comfortable sound-proof and temperature-controlled bedroom and will go to bed and wake up at his/her self-reported usual school-week times. On this night, pre-sleep activities include watching television or reading a book. | Other | Insomnia Group, Non-insomnia Group |
| pre-sleep arousal down-regulationAlso: pre-sleep relaxationOn the "low pre-sleep arousal night", about 30 min before lights-out, a 20 min session of relaxation-driven Virtual Reality (VR) + slow breathing will be conducted. Adolescents will be instructed to perform slow diaphragmatic breathing and to let the VR immersion guide them through this relaxation process. | Other | Insomnia Group, Non-insomnia Group |
| pre-sleep arousal up-regulationAlso: pre-sleep stressOn the "high pre-sleep arousal" night, an anticipatory stress procedure from the Trier Social Stress Test (TSST) will be used to elicit stress-induced ANS activation in the pre-sleep period. About 30 min before lights-out participants will be told that the following morning they will need to prepare and give a 5-min speech in front of a panel of assessors who will judge their performance and ask questions. Participants will be shown the testing room (set up with chairs, video camera, microphone). | Other | Insomnia Group, Non-insomnia Group |
Primary outcome
Average nocturnal heart rate (HR), as a measure of cardiac contractility
Time frame: Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
Heart rate (HR) response to experimental manipulation
Average nocturnal Pre-ejection period (PEP), as a measure of cardiac sympathetic activity
Time frame: Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
Pre-ejection period (PEP) response to experimental manipulation
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 1 May 2023.
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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 No pre-sleep arousal manipulation, pre-sleep arousal down-regulation and pre-sleep arousal up-regulation in people with Insomnia Type; Sleep Disorder, run by SRI International at 1 site in United States.
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 2 inclusion and 13 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 1 May 2023. 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 United States. 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?
Average nocturnal heart rate (HR), as a measure of cardiac contractility (time frame: Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2023.