HypertensionNCT01008176
Restoring Sleep Homeostasis to Lower Blood Pressure
A study testing Sleep extension in people with Hypertension and Pre-hypertension, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Cutting back on sleep duration has developed into a common, highly prevalent habit in the adult population, and may lead to a major health problem. Large epidemiological studies have demonstrated that short sleep duration is associated with increased risk of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Hypertension, Pre-hypertension
- What is being tested?
- Sleep extension
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2012
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current history of prehypertension or stage 1 hypertension
- Sleep duration <= 7 hours/night
Who cannot join
- Sleep disorders
- History of psychiatric or severe medical disorders
- regular medication intake, except anti-hypertensive and birth control medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Restoring Sleep Homeostasis to Lower Blood Pressure: A Behavioral Prevention and Treatment Approach
Cutting back on sleep duration has developed into a common, highly prevalent habit in the adult population, and may lead to a major health problem. Large epidemiological studies have demonstrated that short sleep duration is associated with increased risk of cardiovascular disease (CVD). The investigators' preliminary data on the effects of experimental sleep reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important role in linking sleep loss and CVD risk. With this background, the investigators hypothesize that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective behavioral intervention in the treatment of elevated BP.
The investigators will test this hypothesis in subjects with BP above normal and with short habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to the habitual sleep duration, or subjects will maintain their habitual sleep duration for the following 6 weeks.
Read more
Regarding their first specific aim, the investigators expect that sleep extension across 6 weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers (catecholamines). In particular, the investigators expect that in subjects with mild BP elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP.
This study presents a very first approach in using sleep behavior components for the treatment of elevated BP. Therefore, the investigators' second specific aim will characterize the strength of associations between changes in sleep duration, BP, and inflammation, and they will explore factors that are predictive for these changes. In particular, adiposity, as measured by percent body fat, has frequently been shown to be related to short sleep duration and inflammatory processes, but the role of adiposity in modulating the physiological consequences of changes in sleep duration has never been addressed.
If the investigators' hypothesis is correct, sleep extension may be considered as an additional component in current lifestyle intervention programs in combating and preventing hypertension.
- Conditions
- Hypertension, Pre-hypertension
- Being tested
- Sleep extension
- Keywords
- Hypertension, Sleep, Blood Pressure, Inflammatory Markers
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
Habitual sleep duration is extended by 60min/night over a 6-week time period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: 6 weeks
Secondary outcomes (1)
Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startSep 2005
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Haack, Beth Israel Deaconess Medical Center
- Investigators
- haack monika, md, Principal investigator, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008176
- Sponsor's protocol ID
- 2005P000246
- Status last verified
- Mar 2017
- First submitted
- 20 Oct 2009
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haack M, Serrador J, Cohen D, Simpson N, Meier-Ewert H, Mullington JM. Increasing sleep duration to lower beat-to-beat blood pressure: a pilot study. J Sleep Res. 2013 Jun;22(3):295-304. doi: 10.1111/jsr.12011. Epub 2012 Nov 22.
PubMed 23171375
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Sleep Homeostasis to Lower Blood Pressure: A Behavioral Prevention and Treatment Approach
- ClinicalTrials.gov ID
- NCT01008176
- Acronym / sponsor ID
- 2005P000246
- Conditions
- Hypertension, Pre-hypertension
- Keywords
- Hypertension, Sleep, Blood Pressure, Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Nov 2009 (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.
Cutting back on sleep duration has developed into a common, highly prevalent habit in the adult population, and may lead to a major health problem. Large epidemiological studies have demonstrated that short sleep duration is associated with increased risk of cardiovascular disease (CVD). The investigators' preliminary data on the effects of experimental sleep reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important role in linking sleep loss and CVD risk. With this background, the investigators hypothesize that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective behavioral intervention in the treatment of elevated BP.
The investigators will test this hypothesis in subjects with BP above normal and with short habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to the habitual sleep duration, or subjects will maintain their habitual sleep duration for the following 6 weeks.
Regarding their first specific aim, the investigators expect that sleep extension across 6 weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers (catecholamines). In particular, the investigators expect that in subjects with mild BP elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP.
This study presents a very first approach in using sleep behavior components for the treatment of elevated BP. Therefore, the investigators' second specific aim will characterize the strength of associations between changes in sleep duration, BP, and inflammation, and they will explore factors that are predictive for these changes. In particular, adiposity, as measured by percent body fat, has frequently been shown to be related to short sleep duration and inflammatory processes, but the role of adiposity in modulating the physiological consequences of changes in sleep duration has never been addressed.
If the investigators' hypothesis is correct, sleep extension may be considered as an additional component in current lifestyle intervention programs in combating and preventing hypertension.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current history of prehypertension or stage 1 hypertension
- Sleep duration <= 7 hours/night
Key exclusion criteria (3 listed)
- Sleep disorders
- History of psychiatric or severe medical disorders
- regular medication intake, except anti-hypertensive and birth control medication
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 extensionHabitual sleep duration is extended by 60min/night over a 6-week time period. | Behavioural | – |
Primary outcome
Change in blood pressure
Time frame: 6 weeks
1 secondary outcome
Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine)
Time frame: 6 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 14 Mar 2017.
- Derived from this study: PubMed 23171375Haack M, Serrador J, Cohen D, Simpson N, Meier-Ewert H, Mullington JM. Increasing sleep duration to lower beat-to-beat blood pressure: a pilot study. J Sleep Res. 2013 Jun;22(3):295-304. doi: 10.1111/jsr.12011. Epub 2012 Nov 22.
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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.
haack monika, md principal investigator
doctor
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 in people with Hypertension and Pre-hypertension, run by Beth Israel Deaconess Medical Center 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 2 inclusion and 3 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 14 Mar 2017. 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 blood pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008176, which also lists 1 linked publication.
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 14 Mar 2017.