Long Sleep Duration and Vascular Function

• Sponsor: Texas Tech University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04679051
• Collaborator: American Heart Association (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Behavioral: Sleep duration	N/A

Detailed Description

The aim of this study is to compare the effect of long duration sleep (>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Pulsatile Pressure and Long Sleep Duration on Cerebral Vascular Function
• Actual Study Start Date: Oct 16, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 8 hours time in bed Participants will be asked to spend 8 hours time in bed with the aim of achieving one week of normal sleep duration (7 to 8 hours).	Behavioral: Sleep duration; Participants will be asked to alter time in bed to achieve specified sleep durations.
Experimental: 11 hours time in bed Participants will be asked to spend 11 hours time in bed with the aim of achieving one week of long duration sleep as defined as 9+ hours of sleep.	Behavioral: Sleep duration; Participants will be asked to alter time in bed to achieve specified sleep durations.

Outcome Measures

Primary Outcome Measures

1. Central aortic blood pressure [Change from baseline central blood pressure after exercise]

   Central blood pressure (systolic, diastolic, and pulse pressure) measured during sleep using a Oscar2 device

2. Cerebral vascular reactivity [Change from baseline cerebral vascular reactivity after exercise]

   Blood flow measured in the middle cerebral artery during hypercapnia using transcranial Doppler and cerebral oxygenation measured during cognitive functioning using near infrared spectroscopy

3. Reactive hyperemia [Change from baseline reactive hyperemia after exercise]

   Reactive hyperemia in the forearm (ml/100ml/min) measured using venous occlusion plethysmography

Secondary Outcome Measures

1. Spatial Orientation [Change from baseline cognitive throughput after exercise]

   Throughput (rate of correct responses per given time) measured during a spatial orientation task (Manikin test)

2. Executive function [Change from baseline executive function after exercise]

   Executive function (percent of correct responses) measured during a Stroop color-word test

3. Pressure waveform analysis [Change from baseline pressure waveform after exercise]

   Forward, reflected, and augmentation pressure assessment using radial artery applanation tonometry

4. Mental flexibility [Change from baseline mental flexibility after exercise]

   Throughput (rate of correct responses per given time) measured during a mental flexibility task (Switching test)

5. Carotid pulsatility index [Change from baseline carotid artery pulsatility after exercise]

   Pulsatile behavior of blood flow [(peak systolic/diastolic)/mean flow)] measured using Doppler ultrasound at the common carotid artery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• recreationally active

• reporting no recent history of sleep problems

• not taking sleep-inducing medication

• not diabetic (fasting blood glucose <126 mg/dL)

Exclusion Criteria:

• show symptoms of insomnia

• smoke

• have a personal history of stroke or diabetes

• take birth control pills

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Tech University	Lubbock	Texas	United States	79409-3011

Sponsors and Collaborators

• Texas Tech University
• American Heart Association

Investigators

• Principal Investigator: Joaquin U Gonzales, PhD, Texas Tech University

Study Documents (Full-Text)

• Informed Consent Form - May 19, 2020

More Information

Publications

None provided.

• Responsible Party: Joaquin U Gonzales, PhD, Associate Professor, Texas Tech University
• ClinicalTrials.gov Identifier: NCT04679051
• Other Study ID Numbers: 19IPLOI34760579
• First Posted: Dec 22, 2020
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joaquin U Gonzales, PhD, Associate Professor, Texas Tech University: sleep duration; blood pressure; vasodilation; cognitive function

Study Results

No Results Posted as of Oct 5, 2021