NCT02929810

Brief Summary

Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

6.9 years

First QC Date

October 9, 2016

Last Update Submit

February 5, 2024

Conditions

Sleep Extension

Outcome Measures

Primary Outcomes (1)

  • change in 24-hour mean arterial pressure

    8 weeks

Secondary Outcomes (3)

  • change in baroreflex sensitivity

    8 weeks

  • change in endothelial function

    8 weeks

  • change in insulin sensitivity

    8 weeks

Study Arms (2)

sleep extension

EXPERIMENTAL
Behavioral: sleep extension

sleep maintenance

ACTIVE COMPARATOR
Behavioral: sleep maintenance

Interventions

sleep extensionBEHAVIORAL
sleep extension
sleep maintenanceBEHAVIORAL
sleep maintenance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 65 (inclusive)
  • Gender: both males and females
  • Body mass index (BMI): 18.5-34.9 kg/m2
  • Habitual sleep duration: \<7 hours
  • Presence of either:
  • Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg;
  • Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg
  • Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
  • Not pregnant or breast feeding and not intending to become pregnant or breast feed
  • Not a current smoker or tobacco user
  • Ability to provide written informed consent

You may not qualify if:

  • Vulnerable study populations will be excluded
  • Pregnancy
  • Smoking
  • Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders
  • If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
  • Habitual sleep duration ≥7 hours
  • Excessive alcohol (≥15 drinks/week in men and ≥8 drinks/week in women) and/or excessive caffeine intake (\>400 mg)
  • Currently on a diet and/or actively trying to lose weight
  • Currently or previously (during the past 2 months) participation in any other research study at the discretion of study personnel
  • Blood/plasma donation during the past 2 months
  • Unwillingness or inability to adjust sleep schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Virend Somers, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 9, 2016

First Posted

October 11, 2016

Study Start

October 1, 2016

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

US(1)