Stable Sleep Pattern Before Sleep Loss

NCT06201390 | Completed

• 1 other identifier: IRB2023-1166
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.

Conditions

Sleep

Keywords

sleep variability; blood pressure; sleep deprivation; vasodilation

Outcome Measures

Primary Outcomes (4)

• Change in Peak Reactive Hyperemia

  Peak forearm blood flow will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Peak reactive hyperemia in the forearm (ml/100ml/min) will be measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow is considered the highest blood flow measurement after the blood pressure cuff is deflated.

  pre-intervention; immediately after the intervention

• Change in Arterial Stiffness

  Arterial stiffness will be measured measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Carotid-femoral pulse wave velocity will be used as the measure of arterial stiffness. Radial arterial tonometry will be used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave will then used to calculate pulse wave velocity from transit time and carotid-femoral path length.

  pre-intervention; immediately after the intervention

• Change in Blood Pressure Reactivity

  Blood pressure responses to isometric handgrip exercise will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Mean blood pressure reactivity will be measured using finger plethysmography during 2-minutes of isometric handgrip exercise followed by 3-minutes of post-exercise circulatory arrest.

  pre-intervention; immediately after the intervention

• Change in Cerebral oxygenation

  Regional cerebral oxygenation during a cognitive task will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Oxy- and deoxy-hemoglobin levels in the prefrontal cortex will be measured using a near infrared spectroscopy (NIRs) device.

  pre-intervention; immediately after the intervention

Study Arms (2)

Stable sleep

EXPERIMENTAL

Participants will be asked to maintain a consistent sleep pattern for two weeks.

Behavioral: Sleep consistency

Habitual Sleep

NO INTERVENTION

Participants will be asked to maintain their usual sleep pattern for two weeks.

Interventions

Sleep consistency BEHAVIORAL

Participants will be asked to maintain a consistent bed- and wake-time.

Stable sleep

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men
• years of age

You may not qualify if:

• obese based on BMI \>29 kg/m2
• night-shift work
• prior diagnosis of sleep apnea
• signs of insomnia using the Insomnia Symptom Questionnaire
• a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
• taking medications that alter sleep
• personal history of stroke, coronary heart disease, diabetes mellitus
• taking antihypertensive medications
• smoker (including vaping)

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Kinesiology and Sport Management building

Lubbock, Texas, 79409-3011, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Aneurysm

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joaquin U Gonzales, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 11, 2024
• Study Start: January 25, 2024
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date.
• Access Criteria: Open access

Locations

US (1)