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Sleep Extension and Blood Pressure

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Mayo Clinic

Status

Completed

Conditions

Sleep Extension

Treatments

Behavioral: sleep maintenance
Behavioral: sleep extension

Study type

Interventional

Funder types

Other

Identifiers

NCT02929810
16-000987

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

9 participants in 2 patient groups

sleep extension
Experimental group
Treatment:
Behavioral: sleep extension
sleep maintenance
Active Comparator group
Treatment:
Behavioral: sleep maintenance

Trial contacts and locations

1

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Central trial contact

Madeline Reid

Data sourced from clinicaltrials.gov

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