Sleep ExtensionNCT02929810
Sleep Extension and Blood Pressure
A study testing sleep extension and sleep maintenance in people with Sleep Extension, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Extension
- What is being tested?
- sleep extension and sleep maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial
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.
- Conditions
- Sleep Extension
- Being tested
- sleep extension, sleep maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep extensionBehavioural
sleep maintenanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| sleep extension | Experimental | Not described Receives: Behavioral: sleep extension |
| sleep maintenance | Active comparator | Not described Receives: Behavioral: sleep maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 24-hour mean arterial pressure
Measured: 8 weeks
Secondary outcomes (3)
change in baroreflex sensitivity
Measured: 8 weeks
change in endothelial function
Measured: 8 weeks
change in insulin sensitivity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ExtensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929810
- Sponsor's protocol ID
- 16-000987
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2016
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02929810
- Acronym / sponsor ID
- 16-000987
- Conditions
- Sleep Extension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep extension | Experimental | Behavioral: sleep extension |
| sleep maintenance | Active comparator | Behavioral: sleep maintenance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep extension | Behavioural | sleep extension |
| sleep maintenance | Behavioural | sleep maintenance |
Primary outcome
change in 24-hour mean arterial pressure
Time frame: 8 weeks
3 secondary outcomes
change in baroreflex sensitivity
Time frame: 8 weeks
change in endothelial function
Time frame: 8 weeks
change in insulin sensitivity
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virend Somers, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep extension and sleep maintenance in people with Sleep Extension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 24-hour mean arterial pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.