NCT04679051

Long Sleep Duration and Vascular Function

Completed NA Results posted Last updated 13 January 2023

What this trial tests

NA trial testing Sleep duration in Sleep in 23 participants. Completed in 30 June 2021.

Timeline

16 October 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Texas Tech University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	23
Start date	16 October 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Sleep duration

Conditions studied

• Sleep — all drugs for Sleep →

Sponsor

Texas Tech University

Who can join

Adults 40 to 79, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed Primary · One night during each time in bed condition

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.

Group	Value	95% CI
8 Hours in Bed	-1.5	± 8.9
11hours in Bed	0.5	± 5.2

Change in Cerebral Vascular Reactivity After 11 Hours in Bed Primary · Morning after one week of 8 and 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).

Group	Value	95% CI
8 Hours in Bed	11.9	± 2.8
11 Hours in Bed	11.3	± 1.8

Change in Peak Reactive Hyperemia After 11 Hours in Bed Primary · Morning after one week of 8 and 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.

Group	Value	95% CI
8 Hours in Bed	20.8	± 5.8
11 Hours in Bed	24.2	± 7.2

Change in Arterial Stiffness After 11 Hours in Bed Primary · Morning after one week of 8 and 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.

Group	Value	95% CI
8 Hours in Bed	6.84	± 0.64
11 Hours in Bed	6.96	± 0.64

Change in Spatial Orientation After Aerobic Exercise Secondary · Baseline and after exercise

Score from a Manikin test of spatial orientation that participants took using a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Scores reflect "throughput scores" which is a continuous variable that is the ratio of correct answers per minute during the Manikin test. Higher throughput scores mean better outcome, in this case, better spatial orientation ability. Participants took the Manikin test after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10

Group	Value	95% CI
8 Hours in Bed	7.0	± 4.7
11 Hours in Bed	3.9	± 5.6

Change in Executive Function After Aerobic Exercise Secondary · Baseline and after exercise

Executive function was assessed using a Stroop color-word test that participants took using a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Score reported are number of correct answers. A higher score means a better outcome, in this case, better executive functioning. Participants took the Stoop color-word test after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10 minutes brisk walking at a heart rate considered to be moderate intensity (50-70%

Group	Value	95% CI
8 Hours Time in Bed	4.5	± 5.4
11 Hours Time in Bed	2.4	± 6.8

Change in Mental Flexibility After Aerobic Exercise Secondary · Baseline and after exercise

Mental flexibility was assessed using a Switching task that participants took on a computer with automated software (Automated Neuropsychological Assessment Metrics, known as ANAM). Scores reflect "throughput scores" which is a continuous variable that is the ratio of correct answers per minute during the Manikin test. Higher throughput scores mean better outcome, in this case, better mental flexibility. Participants took the Switching task after one week of 8 and 11 hours in bed (i.e., baseline) then the morning after one day of aerobic exercise. Exercise consisted of three sessions of 10 min

Group	Value	95% CI
8 Hours in Bed	2.8	± 4.9
11 Hours in Bed	1.6	± 3.3

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of five nights of sleep extension on peripheral vascular function: a randomized crossover investigation into long sleep duration.
   Gonzales JU, Clark C, Anderson T. · · 2022 · cited 6× · PMID 35180478 · DOI 10.1016/j.sleep.2022.01.021
2. Six nights of sleep extension increases regional cerebral oxygenation without modifying cognitive performance at rest or following acute aerobic exercise.
   Clark C, Rivas E, Gonzales JU. · · 2022 · cited 5× · PMID 35266244 · DOI 10.1111/jsr.13582