Trial Outcomes & Findings for Long Sleep Duration and Vascular Function (NCT NCT04679051)

NCT ID: NCT04679051

Last Updated: 2023-01-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: One night during each time in bed condition
• Results posted on: 2023-01-13

Participant Flow

34 participants were screened for eligibility between October 16, 2019 and May 24, 2021at Texas Tech University in Lubbock, TX.

23 of 34 participants were randomized. Of those not randomized, 8 did not meet inclusion criteria and 3 declined to participate.

Participant milestones

Measure	8, Then 11 Hours in Bed Participants were first asked to spend 8 hours in bed for one week. After 1 night of washout, participants were then asked to spend 11 hours in bed for one week.	11, Then 8 Hours in Bed Participants were first asked to spend 11 hours in bed for one week. After 1 night of washout, participants were then asked to spend 8 hours in bed for one week.
Overall Study STARTED	12	11
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	8, Then 11 Hours in Bed Participants were first asked to spend 8 hours in bed for one week. After 1 night of washout, participants were then asked to spend 11 hours in bed for one week.	11, Then 8 Hours in Bed Participants were first asked to spend 11 hours in bed for one week. After 1 night of washout, participants were then asked to spend 8 hours in bed for one week.
Overall Study felt tired after restricted time in bed	3	0
Overall Study discomfort with blood pressure cuff	2	0
Overall Study scheduling conflict	1	1
Overall Study Protocol Violation	0	4

Baseline Characteristics

Long Sleep Duration and Vascular Function

Baseline characteristics by cohort

Measure	8, Then 11 Hours in Bed n=6 Participants Participants were first asked to spend 8 hours in bed for one week. After 1 night of washout, participants were then asked to spend 11 hours in bed for one week.	11, Then 8 Hours in Bed n=6 Participants Participants were first asked to spend 11 hours in bed for one week. After 1 night of washout, participants were then asked to spend 8 hours in bed for one week.	Total n=12 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 6 • n=5 Participants	43 years STANDARD_DEVIATION 3 • n=7 Participants	45 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body mass index	26 kg/m^2 STANDARD_DEVIATION 3 • n=5 Participants	24 kg/m^2 STANDARD_DEVIATION 5 • n=7 Participants	26 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants
Seated Systolic Blood Pressure	118 mm Hg STANDARD_DEVIATION 10 • n=5 Participants	111 mm Hg STANDARD_DEVIATION 8 • n=7 Participants	114 mm Hg STANDARD_DEVIATION 9 • n=5 Participants
Seated Diastolic Blood Pressure	75 mm Hg STANDARD_DEVIATION 6 • n=5 Participants	73 mm Hg STANDARD_DEVIATION 10 • n=7 Participants	74 mm Hg STANDARD_DEVIATION 8 • n=5 Participants

PRIMARY outcome

Timeframe: One night during each time in bed condition

Population: All participants who completed all study visits were included in the analysis.

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.

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change From Wake in Central Aortic Pulse Pressure After 11 Hours in Bed	-1.5 mm Hg Standard Deviation 8.9	0.5 mm Hg Standard Deviation 5.2

PRIMARY outcome

Timeframe: Morning after one week of 8 and 11 hours in bed

Population: The middle cerebral artery could not be located in 3 participants, so data was analyzed in 9 participants that had complete data.

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).

Outcome measures

Measure	8 Hours in Bed n=9 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=9 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Cerebral Vascular Reactivity After 11 Hours in Bed	11.9 percent change/Torr Standard Deviation 2.8	11.3 percent change/Torr Standard Deviation 1.8

PRIMARY outcome

Timeframe: Morning after one week of 8 and 11 hours in bed

Population: All participants who completed all study visits were included in the analysis.

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.

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Peak Reactive Hyperemia After 11 Hours in Bed	20.8 ml/100ml/min Standard Deviation 5.8	24.2 ml/100ml/min Standard Deviation 7.2

PRIMARY outcome

Timeframe: Morning after one week of 8 and 11 hours in bed

Population: All participants who completed all study visits were included in the analysis.

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.

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Arterial Stiffness After 11 Hours in Bed	6.84 m/s Standard Deviation 0.64	6.96 m/s Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline and after exercise

Population: All participants who completed all study visits were included in the analysis.

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 minutes brisk walking at a heart rate considered to be moderate intensity (50-70% of age-predicted maximal heart rate). Results reported reflect the change in throughput scores after exercise (morning after exercise minus baseline).

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Spatial Orientation After Aerobic Exercise	7.0 correct answers per minute Standard Deviation 4.7	3.9 correct answers per minute Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline and after exercise

Population: All participants who completed all study visits were included in the analysis.

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% of age-predicted maximal heart rate). Results reported reflect the change in score after exercise (morning after exercise minus baseline).

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Executive Function After Aerobic Exercise	4.5 correct answers Standard Deviation 5.4	2.4 correct answers Standard Deviation 6.8

SECONDARY outcome

Timeframe: Baseline and after exercise

Population: All participants who completed all study visits were included in the analysis.

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 minutes brisk walking at a heart rate considered to be moderate intensity (50-70% of age-predicted maximal heart rate). Results reported reflect the change in throughput scores after exercise (morning after exercise minus baseline).

Outcome measures

Measure	8 Hours in Bed n=12 Participants Condition in which participants spent 8 hours in bed for one week.	11hours in Bed n=12 Participants Condition in which participants spent 11 hours in bed for one week.
Change in Mental Flexibility After Aerobic Exercise	2.8 correct answers per minute Standard Deviation 4.9	1.6 correct answers per minute Standard Deviation 3.3

Adverse Events

8 Hours in Bed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

11 Hours in Bed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joaquin U Gonzales

Texas Tech University

Phone: 806 834 5944

Email: joaquin.gonzales@ttu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place