NCT04146857

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

October 25, 2019

Last Update Submit

July 7, 2022

Conditions

HypoxiaSleepHealthy

Keywords

HypoxiaSleepHeart rate variabilitySleep architecture

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Mean RR interval measured by polysomnography (ms)

    During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition

Secondary Outcomes (17)

  • Heart rate variability

    During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition

  • Sleep Efficiency (SE)

    During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

  • Wake After Sleep Onset (WASO)

    During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

  • Sleep Onset Latency (SOL)

    During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

  • Low Frequency / High Frequency Band

    During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

  • +12 more secondary outcomes

Study Arms (3)

Normoxia

PLACEBO COMPARATOR

20.9% oxygen

Other: Normoxia

Hypoxia 1

ACTIVE COMPARATOR

15.0% oxygen

Other: Hypoxia 1

Hypoxia 2

ACTIVE COMPARATOR

12.8% oxygen

Other: Hypoxia 2

Interventions

NormoxiaOTHER

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

Normoxia
Hypoxia 1OTHER

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

Hypoxia 1
Hypoxia 2OTHER

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

Hypoxia 2

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35685284RESULT

Related Links

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anja Mähler, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Alain Riveros, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 31, 2019

Study Start

October 30, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

DE(1)