Stable Sleep Pattern Before Sleep Loss

NCT ID: NCT06201390

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-02-08

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.

Detailed Description

Purpose and hypothesis The aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function.

Study design and procedures Thirty adults (15 men, 15 women) 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. Bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. Sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. Resting 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. Total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Stable sleep

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

Group Type: EXPERIMENTAL

Sleep consistency

Intervention Type: BEHAVIORAL

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

Habitual Sleep

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep consistency

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women and men
• 35-64 years of age

Exclusion Criteria

• 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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University

OTHER

Sponsor Role: lead

Responsible Party

Joaquin U Gonzales, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquin U Gonzales, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

Kinesiology and Sport Management building

Lubbock, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB2023-1166

Identifier Type: -

Identifier Source: org_study_id