Sleep Extension and Blood Pressure

NCT ID: NCT02929810

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-09-07

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Extension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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sleep extension

Group Type EXPERIMENTAL

sleep extension

Intervention Type BEHAVIORAL

sleep maintenance

Group Type ACTIVE_COMPARATOR

sleep maintenance

Intervention Type BEHAVIORAL

Interventions

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sleep extension

Intervention Type BEHAVIORAL

sleep maintenance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Virend Somers, MD, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virend Somers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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16-000987

Identifier Type: -

Identifier Source: org_study_id

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