Clinical trial NCT04146857: Autonomic Activity During Nap Under Hypoxia
Official title: Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Sleep
Healthy
Keywords: Hypoxia
Sleep
Heart rate variability
Sleep architecture
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart rate variability
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition
Secondary outcomes:
measure: Heart rate variability
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition
measure: Sleep Efficiency (SE)
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Wake After Sleep Onset (WASO)
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Sleep Onset Latency (SOL)
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Low Frequency / High Frequency Band
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Standard Deviation 1 / Standard Deviation 2
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: RR intervals longer than 50 ms
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Core Body Temperature
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Skin Temperature
timeFrame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Digit Span Task
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Psychomotor Vigilance Task Subscale 1
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Psychomotor Vigilance Task Subscale 2
timeFrame: After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Color Stroope Task Subscale 1
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Color Stroope Task Subscale 2
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Color Stroope Task Subscale 3
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Color Stroope Task Subscale 4
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
measure: Color Stroope Task Subscale 5
timeFrame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental & Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Alain Riveros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.