Obstructive Sleep Apnoea SyndromeNCT02515071
A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).
A study testing Dietary nitrate in people with Obstructive Sleep Apnoea Syndrome, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnoea Syndrome
- What is being tested?
- Dietary nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2015to Sep 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable,
- Untreated OSAS out-patients
Who cannot join
- Using continuous positive airways pressure therapy
- Pulmonary hypertension
- Active CVD
- Active musculo-skeletal conditions
- Taking vasodilators
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Nitrate for OSAS: a Randomized, Placebo-controlled, Crossover Trial.
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
Read the detailed description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice.
This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.
- Conditions
- Obstructive Sleep Apnoea Syndrome
- Being tested
- Dietary nitrate, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary nitrateDietary supplement
Also called Beetroot juice
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
PlaceboDietary supplement
Also called Nitrate depleted beetroot juice
140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate rich beetroot juice | Experimental | Concentrated, beetroot juice is a rich source of dietary nitrate. Receives: Dietary Supplement: Dietary nitrate |
| Nitrate depleted placebo beetroot juice | Placebo comparator | Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ambulatory nocturnal blood pressure
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Secondary outcomes (8)
Difference in 24h blood pressure
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in plasma nitrate and nitrite
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in fasting glucose
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in OSAS symptomatology
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in 2h post OGT glucose
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in overnight oximetry
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in exhaled nitric oxide
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Difference in vigilance scores derived from the Conner's Continuous Performance Test.
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Measured: Day 1, day 15, day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea SyndromeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, Connolly Hospital Blanchardstown
- Responsible party
- Sponsor
- Investigators
- Liam Cormican, MD, Principal investigator, Connolly Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515071
- Sponsor's protocol ID
- Chronic NO3- in OSAS
- Status last verified
- Aug 2015
- First submitted
- 7 Jan 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Nitrate for OSAS: a Randomized, Placebo-controlled, Crossover Trial.
- ClinicalTrials.gov ID
- NCT02515071
- Acronym / sponsor ID
- Chronic NO3- in OSAS
- Conditions
- Obstructive Sleep Apnoea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- University College Dublin, Connolly Hospital Blanchardstown
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Aug 2015 (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.
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
Detailed description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice.
This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate rich beetroot juice | Experimental | Dietary Supplement: Dietary nitrateConcentrated, beetroot juice is a rich source of dietary nitrate. |
| Nitrate depleted placebo beetroot juice | Placebo comparator | Dietary Supplement: PlaceboPlacebo beetroot juice is identical to active beetroot juice in every way except nitrate content. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically stable,
- Untreated OSAS out-patients
Key exclusion criteria (6 listed)
- Using continuous positive airways pressure therapy
- Pulmonary hypertension
- Active CVD
- Active musculo-skeletal conditions
- Taking vasodilators
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 |
|---|---|---|
| Dietary nitrateAlso: Beetroot juice140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects. | Dietary supplement | Nitrate rich beetroot juice |
| PlaceboAlso: Nitrate depleted beetroot juice140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects. | Dietary supplement | Nitrate depleted placebo beetroot juice |
Primary outcome
Difference in ambulatory nocturnal blood pressure
Time frame: Day 1, day 15, day 29
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
8 secondary outcomes
Difference in 24h blood pressure
Time frame: Day 1, day 15, day 29
Difference in plasma nitrate and nitrite
Time frame: Day 1, day 15, day 29
Difference in fasting glucose
Time frame: Day 1, day 15, day 29
Difference in OSAS symptomatology
Time frame: Day 1, day 15, day 29
Difference in 2h post OGT glucose
Time frame: Day 1, day 15, day 29
Difference in overnight oximetry
Time frame: Day 1, day 15, day 29
Difference in exhaled nitric oxide
Time frame: Day 1, day 15, day 29
Difference in vigilance scores derived from the Conner's Continuous Performance Test.
Time frame: Day 1, day 15, day 29
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 23 Oct 2015.
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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.
Liam Cormican, MD principal investigator
Connolly Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary nitrate in people with Obstructive Sleep Apnoea Syndrome, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 6 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 23 Oct 2015. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Difference in ambulatory nocturnal blood pressure (time frame: Day 1, day 15, day 29). 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 23 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.