Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this interventional study is to differentiate the effects of an acute partial sleep deprivation intervention on markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing in active vs sedentary individuals. The main aims of the project are:
Participants will be divided into two groups based on aerobic activity level - active or sedentary - and assessed for markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing before and after three days of normal sleep and three days of partially deprived sleep (i.e., 30% reduction in total time in bed).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Sleep | No Intervention | ||
| Acute Partial Sleep Deprivation | Experimental | 30% reduction in habitual time in bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial Sleep Deprivation | Other | 30% reduction in habitual time in bed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness | Carotid-femoral pulse wave velocity measured via applanation tonometry | Following 3-days of Acute Sleep Deprivation (i.e., 30% reduction in total time in bed) as well as following 3-days of Normal Sleep (i.e., 100% habitual time in bed); performed in a randomized order |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Sciences and Medicine | Tallahassee | Florida | 32301 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Group: Normal Sleep, Then Acute Sleep Deprivation | Individuals performing >150 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). |
| FG001 | Active Group: Acute Sleep Deprivation, Then Normal Sleep | Individuals performing >150 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. |
| FG002 | Sedentary Group: Normal Sleep, Then Acute Sleep Deprivation | Individuals performing <60 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). |
| FG003 | Sedentary Group: Acute Sleep Deprivation, Then Normal Sleep | Individuals performing <60 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 days) |
| |||||||||||||
| Washout (7 days) |
| |||||||||||||
| Second Intervention (4 days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Group: Normal Sleep, Then Acute Sleep Deprivation | Individuals performing >150 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Arterial Stiffness | Carotid-femoral pulse wave velocity measured via applanation tonometry | Posted | Mean | Standard Deviation | meters per second | Following 3-days of Acute Sleep Deprivation (i.e., 30% reduction in total time in bed) as well as following 3-days of Normal Sleep (i.e., 100% habitual time in bed); performed in a randomized order |
|
from enrollment through study completion, an average of 1 month
no differences
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group: Normal Sleep | Individuals performing >150 minutes of aerobic exercise per week who completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Ormsbee, PhD | Florida State University | 8506451016 | issm@fsu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2025 | Mar 4, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Active Group: Acute Sleep Deprivation, Then Normal Sleep | Individuals performing >150 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. |
| BG002 | Sedentary Group: Normal Sleep, Then Acute Sleep Deprivation | Individuals performing <60 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). |
| BG003 | Sedentary Group: Acute Sleep Deprivation, Then Normal Sleep | Individuals performing <60 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation). After a 7-day washout period, they then completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Sedentary Group: Normal Sleep | Individuals performing <60 minutes of aerobic exercise per week who first completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed |
| OG003 | Sedentary Group: Acute Sleep Deprivation | Individuals performing <60 minutes of aerobic exercise per week who completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation) |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Active Group: Acute Sleep Deprivation | Individuals performing >150 minutes of aerobic exercise per week who completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation) | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Sedentary Group: Normal Sleep | Individuals performing <60 minutes of aerobic exercise per week who completed 3 nights of bed and wake time prescriptions eliciting 100% habitual time in bed | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Sedentary Group: Acute Sleep Deprivation | Individuals performing <60 minutes of aerobic exercise per week who completed 3 nights of bed and wake time prescriptions eliciting 70% habitual time in bed (i.e., a 30% reduction in total time in bed; acute sleep deprivation) | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided