Autonomic Activity During Nap Under Hypoxia

Healthy Clinical Trial

— NAPOXIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146857
• Other study ID #: NAPOXIA
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition, we will investigate sleep architecture, vigilance, attention and memory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hypoxia
• Sleep

Intervention

Other:
• Normoxia
Nap in hypoxia chamber at 20.9% oxygen (36 m asl)
• Hypoxia 1
Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)
• Hypoxia 2
Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)

Locations

Country	Name	City	State
Germany	Experimental & Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Riveros-Rivera A, Penzel T, Gunga HC, Opatz O, Paul F, Klug L, Boschmann M, Mähler 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Mean RR interval measured by polysomnography (ms)	During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition
Secondary	Heart rate variability	Mean RR interval measured by polysomnography (ms)	During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition
Secondary	Sleep Efficiency (SE)	Measured by continuous polysomnography (min)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Wake After Sleep Onset (WASO)	Measured by continuous polysomnography (min)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Sleep Onset Latency (SOL)	Measured by continuous polysomnography (min)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Low Frequency / High Frequency Band	Mean LF/HF ratio measured by continuous ECG	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Standard Deviation 1 / Standard Deviation 2	Mean SD1/SD2 ratio measured by continuous ECG	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	RR intervals longer than 50 ms	Percentage pNN50 measured by continuous ECG (%)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Core Body Temperature	Mean temperature measured by continuous double sensor monitoring (°C)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Skin Temperature	Mean temperature measured by continuous double sensor monitoring (°C)	During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Digit Span Task	Longest memorized digit series (n, normal range 5-9, higher is better)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Psychomotor Vigilance Task Subscale 1	Number of lapses (normal range 0-6, higher is worse)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Psychomotor Vigilance Task Subscale 2	Mean reaction time (normal range 100-500 ms, higher is worse)	After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Color Stroope Task Subscale 1	Number of incongruency errors (normal range 0-5, higher is worse)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Color Stroope Task Subscale 2	Congruent response time (normal range 400-500 ms, higher is worse)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Color Stroope Task Subscale 3	Incongruent response time (normal range 600-800 ms, higher is worse)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Color Stroope Task Subscale 4	Congruent accuracy (above 95% is normal, higher is better)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)
Secondary	Color Stroope Task Subscale 5	Incongruent accuracy (above 85% is normal, higher is better)	After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

External Links

•   Results publication