Autonomic Activity During Nap Under Hypoxia

NCT ID: NCT04146857

Last Updated: 2022-07-11

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-12-30

Brief Summary

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Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.

Detailed Description

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Conditions

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Hypoxia Sleep Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Normoxia

20.9% oxygen

Group Type PLACEBO_COMPARATOR

Normoxia

Intervention Type OTHER

Nap in hypoxia chamber at 20.9% oxygen (36 m asl)

Hypoxia 1

15.0% oxygen

Group Type ACTIVE_COMPARATOR

Hypoxia 1

Intervention Type OTHER

Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)

Hypoxia 2

12.8% oxygen

Group Type ACTIVE_COMPARATOR

Hypoxia 2

Intervention Type OTHER

Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)

Interventions

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Normoxia

Nap in hypoxia chamber at 20.9% oxygen (36 m asl)

Intervention Type OTHER

Hypoxia 1

Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)

Intervention Type OTHER

Hypoxia 2

Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Age 25-45 years
* BMI 20 - 28 kg/m\^2

Exclusion Criteria

* Severe, manifest illnesses in need of treatment
* Postoperative phases
* Acute and chronic infections
* Sleep disorders such as sleep apnea, insomnia or somnolence
* Altitude exposure (\> 2500 m asl) within 6 months before enrollment
* Regular migraines
* Smoking
* Athletes
* Significant weight change within 1 month before enrollment
* Inability to understand significance and scope of the study
* Drug or alcohol abuse
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Anja Maehler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anja Mähler, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Alain Riveros, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Experimental & Clinical Research Center

Berlin, , Germany

Site Status

Countries

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Germany

References

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Riveros-Rivera A, Penzel T, Gunga HC, Opatz O, Paul F, Klug L, Boschmann M, Mahler A. Hypoxia Differentially Affects Healthy Men and Women During a Daytime Nap With a Dose-Response Relationship: a Randomized, Cross-Over Pilot Study. Front Physiol. 2022 May 24;13:899636. doi: 10.3389/fphys.2022.899636. eCollection 2022.

Reference Type RESULT
PMID: 35685284 (View on PubMed)

Related Links

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Other Identifiers

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NAPOXIA

Identifier Type: -

Identifier Source: org_study_id

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