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HypoxiaNAPOXIANCT04146857

Autonomic Activity During Nap Under Hypoxia

A study testing Normoxia, Hypoxia 1 and Hypoxia 2 in people with Hypoxia and Sleep, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia, Sleep, Healthy
What is being tested?
Normoxia, Hypoxia 1 and Hypoxia 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteGermany
Study dates
30 Oct 2019to 30 Dec 2020
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • Smoking
  • Athletes
  • Significant weight change within 1 month before enrollment
  • Inability to understand significance and scope of the study
  • Drug or alcohol abuse

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Experimental & Clinical Research Center

    Berlin, 13125

Other trials in Germany

About this study

Official title: Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)

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.

Conditions
Hypoxia, Sleep, Healthy
Being tested
Normoxia, Hypoxia 1, Hypoxia 2
Keywords
Hypoxia, Sleep, Heart rate variability, Sleep architecture
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NormoxiaOther

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

  • Hypoxia 1Other

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

  • Hypoxia 2Other

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

Study groups in NCT04146857
Study groupRoleWhat they receive
NormoxiaPlacebo comparator20.9% oxygen
Receives: Other: Normoxia
Hypoxia 1Active comparator15.0% oxygen
Receives: Other: Hypoxia 1
Hypoxia 2Active comparator12.8% oxygen
Receives: Other: Hypoxia 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate variability

    Mean RR interval measured by polysomnography (ms)

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

Secondary outcomes (17)

  1. Heart rate variability

    Mean RR interval measured by polysomnography (ms)

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

  2. Sleep Efficiency (SE)

    Measured by continuous polysomnography (min)

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

  3. Wake After Sleep Onset (WASO)

    Measured by continuous polysomnography (min)

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

  4. Sleep Onset Latency (SOL)

    Measured by continuous polysomnography (min)

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

  5. Low Frequency / High Frequency Band

    Mean LF/HF ratio measured by continuous ECG

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

  6. Standard Deviation 1 / Standard Deviation 2

    Mean SD1/SD2 ratio measured by continuous ECG

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

  7. RR intervals longer than 50 ms

    Percentage pNN50 measured by continuous ECG (%)

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

  8. Core Body Temperature

    Mean temperature measured by continuous double sensor monitoring (°C)

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

  9. Skin Temperature

    Mean temperature measured by continuous double sensor monitoring (°C)

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

  10. Digit Span Task

    Longest memorized digit series (n, normal range 5-9, higher is better)

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

  11. Psychomotor Vigilance Task Subscale 1

    Number of lapses (normal range 0-6, higher is worse)

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

  12. Psychomotor Vigilance Task Subscale 2

    Mean reaction time (normal range 100-500 ms, higher is worse)

    Measured: After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

  13. Color Stroope Task Subscale 1

    Number of incongruency errors (normal range 0-5, higher is worse)

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

  14. Color Stroope Task Subscale 2

    Congruent response time (normal range 400-500 ms, higher is worse)

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

  15. Color Stroope Task Subscale 3

    Incongruent response time (normal range 600-800 ms, higher is worse)

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

  16. Color Stroope Task Subscale 4

    Congruent accuracy (above 95% is normal, higher is better)

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

  17. Color Stroope Task Subscale 5

    Incongruent accuracy (above 85% is normal, higher is better)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start30 Oct 2019
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146857
Sponsor's protocol ID
NAPOXIA
Acronym
NAPOXIA
Status last verified
Jul 2022
First submitted
25 Oct 2019
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

Publications

  • 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.

    PubMed 35685284

Questions about this trial

What is this clinical trial studying?

A study testing Normoxia, Hypoxia 1 and Hypoxia 2 in people with Hypoxia and Sleep, run by Charite University, Berlin, Germany at 1 site in Germany.

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 3 inclusion and 11 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 11 Jul 2022. 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 Germany. 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?

Heart rate variability (time frame: During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition). 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 NCT04146857, 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 11 Jul 2022.

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