Long Sleep Duration and Vascular Function

NCT04679051 | Completed Results

• 1 other identifier: 19IPLOI34760579
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

sleep duration; blood pressure; vasodilation; cognitive function

Outcome Measures

Primary Outcomes (4)

• Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed

  Central aortic pulse pressure was measured one night during the week of 8 hours in bed, then again one night during the week of 11 hours in bed. Blood pressure was measured using an Oscar2 ambulatory blood pressure device. The device started recordings one hour prior to sleep and was programmed to take measurements once every 30 minutes during sleep until 10:00pm then every 45 minutes after 10:00pm until participants arose from bed. The change in central aortic pulse pressure from being awake to being asleep was compared between 8 and 11 hours in bed conditions.

  One night during each time in bed condition

• Change in Cerebral Vascular Reactivity After 11 Hours in Bed

  Blood flow measured in the middle cerebral artery during hypercapnia was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Cerebral blood flow was measured using transcranial Doppler during 3 minutes of transient hypercapnia induced by rebreathing. Cerebral vascular reactivity was considered as the percent increase in cerebral blood flow at the end of 3 minutes of rebreathing relative to the Torr change in end-tidal carbon dioxide (percent change/Torr).

  Morning after one week of 8 and 11 hours in bed

• Change in Peak Reactive Hyperemia After 11 Hours in Bed

  Peak forearm blood flow was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Peak reactive hyperemia in the forearm (ml/100ml/min) was measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow was considered the highest blood flow measurement after the blood pressure cuff was deflated.

  Morning after one week of 8 and 11 hours in bed

• Change in Arterial Stiffness After 11 Hours in Bed

  Arterial stiffness was measured after one week of 8 hours in bed, then again after one week of 11 hours in bed. Carotid-femoral pulse wave velocity was used as the measure of arterial stiffness. Radial arterial tonometry was used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave was then used to calculate pulse wave velocity from transit time and carotid-femoral path length.

  Morning after one week of 8 and 11 hours in bed

Secondary Outcomes (3)

• Change in Spatial Orientation After Aerobic Exercise

  Baseline and after exercise

• Change in Executive Function After Aerobic Exercise

  Baseline and after exercise

• Change in Mental Flexibility After Aerobic Exercise

  Baseline and after exercise

Study Arms (2)

8 hours time in bed

EXPERIMENTAL

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

11 hours time in bed

EXPERIMENTAL

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

Interventions

Sleep duration BEHAVIORAL

Participants will be asked to alter time in bed to achieve specified sleep durations.

11 hours time in bed; 8 hours time in bed

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recreationally active
• reporting no recent history of sleep problems
• not taking sleep-inducing medication
• not diabetic (fasting blood glucose \<126 mg/dL)

You may not qualify if:

• show symptoms of insomnia
• smoke
• have a personal history of stroke or diabetes
• take birth control pills

Sponsors & Collaborators

• Texas Tech University: lead
• American Heart Association: collaborator

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409-3011, United States

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Sleep Duration

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sleep; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Joaquin U Gonzales
• Organization: Texas Tech University

joaquin.gonzales@ttu.edu

806 834 5944

Study Officials

• Joaquin U Gonzales, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: 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.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 22, 2020
• Study Start: October 16, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 13, 2023
• Results First Posted: January 12, 2023

Record last verified: 2023-01

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)