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Intermittent Hypoxia for Sleep Apnea

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how reducing blood flow to the brain affects breathing patterns during sleep. Researchers are testing a drug that lowers cerebral blood flow and examining its interaction with different oxygen levels during sleep: normal room air and intermittent low oxygen (similar to a high-altitude environment). Participants will be divided into groups to receive either the drug or a placebo while sleeping under these oxygen conditions. The trial seeks healthy adults aged 18-45 who live in Calgary and do not have medical conditions or take blood pressure medications. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that participants should not be taking any blood pressure medications. If you are on such medications, you would need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated that using medications to lower blood flow to the brain is generally safe. For instance, a skin patch with glyceryl trinitrate, which reduces blood pressure, maintained normal brain blood flow in individuals who recently experienced a stroke. This suggests the treatment is well-tolerated in specific situations.

Regarding intermittent hypoxia sleep (short periods of low oxygen during sleep), research indicates it is mostly safe. Studies have shown it can lead to positive changes in the brain and might assist with certain conditions. However, monitoring for any effects on the heart is important.

Normoxia sleep, which involves regular sleep with normal oxygen levels, does not present significant safety concerns and resembles the air breathed daily.

Overall, current data suggests the treatments in this trial are well-tolerated. However, since treatments can affect individuals differently, discussing any concerns with the research team is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores how cerebral blood flow and breathing patterns change during sleep in different oxygen conditions. Unlike traditional methods that might only focus on sleep quality or breathing issues, this trial examines how a drug can specifically lower cerebral blood flow and how that interacts with intermittent hypoxia (periods of reduced oxygen levels) during sleep. This could uncover new insights into managing conditions related to sleep-disordered breathing or brain blood flow, potentially leading to more effective and targeted treatments.

What evidence suggests that this trial's treatments could be effective for ventilatory chemoreflexes?

This trial will compare treatments involving intermittent hypoxia (IH) and cerebral blood flow (CBF) modulation. Research has shown that IH training might boost blood flow to the brain and improve cognitive skills. One study found that a single IH session can increase brain blood flow and might aid in tasks requiring planning and decision-making. Other studies suggest IH could benefit various organs and enhance exercise endurance. In this trial, some participants will experience IH sleep with either a drug that lowers CBF or a placebo. Research on reducing brain blood flow indicates it can impact cognition, especially in low-oxygen situations. Participants will also experience normoxia sleep with either a drug lowering CBF or a placebo. Overall, early evidence suggests these treatments could affect brain blood flow and related functions, but further research is needed to confirm these effects.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-45 who have lived in Calgary for at least a year, do not have any major medical conditions, are not on blood pressure meds, are not lactose intolerant, and do not smoke. People with certain diseases or allergies, pregnant individuals, those with obesity or sleep disorders cannot join.

Inclusion Criteria

Healthy adults
Aged 18-45 years
Living in Calgary for the past one year
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Exclusion Criteria

History of cerebrovascular, cardio-respiratory, renal, or metabolic diseases
History of bleeding disorders and upper gastrointestinal diseases such as peptic ulcer disease
Pregnancy, obesity, or sleep-disordered breathing
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pharmacological intervention to manipulate cerebral blood flow and sleep under normoxia or intermittent hypoxia

18 months
Multiple sessions with intervals for washout periods

Follow-up

Participants are monitored for changes in cerebral blood flow and ventilatory chemoreflexes after treatment

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Drug Lowering Cerebral Blood Flow (CBF)
  • Intermittent Hypoxia Sleep
  • Normoxia Sleep
  • Placebo

Trial Overview

The study tests how lowering brain blood flow affects breathing responses during sleep under normal oxygen and low oxygen (intermittent hypoxia) conditions. Participants receive either a drug or placebo in different combinations using a randomized cross-over design.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CBF Lowering and IH SleepExperimental Treatment1 Intervention
Group II: CBF Lowering and Normoxia SleepActive Control1 Intervention
Group III: Placebo and IH SleepPlacebo Group1 Intervention
Group IV: Placebo and Normoxia SleepPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Citations

Intermittent hypoxia training improves cerebral blood flow ...

This study aimed to evaluate the impact of a moderate short‐term intermittent hypoxia protocol on cerebral blood flow and cognitive performance.

A Single Bout of Intermittent Hypoxia Increases Cerebral ...

A Single Bout of Intermittent Hypoxia Increases Cerebral Blood Flow and Supports an Executive Function Benefit. Denait Haile,. Denait Haile.

Investigating the Combined Effects of Intermittent Hypoxia ...

Outcome measures include comprehensive cognitive testing (global cognition, reaction time, executive function, and divided attention), assessments of autonomy ( ...

Impact of intermittent hypoxia on human vascular ...

Exposure to intermittent hypoxia (IH) ≥15 times per hour is believed to be the primary mechanism for the increased risk of cerebrovascular and ...

Variable cerebral blood flow responsiveness to acute ...

The data included in this article were collected as part of a randomized cross-over clinical trial, but do not assess the outcomes of this trial: Improving ...

Impact of intravenous antihypertensive therapy on cerebral ...

Most iv antihypertensive agents do not significantly affect CBF in clinical dose ranges; however, nitroprusside and nitroglycerin can reduce CBF under specific ...

Effect of drug interventions on cerebral hemodynamics ... - PMC

Transdermal glyceryl trinitrate lowers blood pressure and maintains cerebral blood flow in recent stroke. ... Safety data from the lacunar intervention-1 ...

Effect of Medications on Cerebral Blood Flow

Opioids: Slightly reduce CBF and CMRO2. Their largest effect on CBF is indirect through hypoventilation-induced hypercarbia, which increases CBF ...

Effects of vasodilating medications on cerebral...

Blood pressure (BP)-lowering treatment significantly reduces the risk of recurrent stroke and probably reduces cerebral small vessel disease. Vasodilating ...

The Effect of Blood Pressure on Cerebral Blood Flow ...

General anesthesia often reduces blood pressure whereby blood flow to the brain and other vital organs may become insufficient. Thus, medicine is often ...