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CompletedNCT02929810Updated Feb 6, 2024

Sleep Extension and Blood Pressure

An interventional study of sleep extension and sleep maintenance in Sleep Extension, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Extension
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    sleep extension

    Behavioral: sleep extension

  • Active comparator
    sleep maintenance

    Behavioral: sleep maintenance

Interventions

  • Behavioralsleep extension
  • Behavioralsleep maintenance
06

What researchers measure

Primary outcomes

  1. change in 24-hour mean arterial pressure

    Time frame: 8 weeks

Secondary outcomes

  1. change in baroreflex sensitivity

    Time frame: 8 weeks

  2. change in endothelial function

    Time frame: 8 weeks

  3. change in insulin sensitivity

    Time frame: 8 weeks

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02929810
Lead sponsor
Mayo Clinic
Responsible party
Virend Somers, MD, PhD (Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Oct 11, 2016
Start date
Oct 2016
Primary completion
Sep 7, 2023
Completion
Sep 7, 2023
Last update
Feb 6, 2024

Study contacts

Virend Somers, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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