Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT04146857
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2019-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autonomic Activity During Nap Under Hypoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition', 'description': 'Mean RR interval measured by polysomnography (ms)'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition', 'description': 'Mean RR interval measured by polysomnography (ms)'}, {'measure': 'Sleep Efficiency (SE)', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Measured by continuous polysomnography (min)'}, {'measure': 'Wake After Sleep Onset (WASO)', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Measured by continuous polysomnography (min)'}, {'measure': 'Sleep Onset Latency (SOL)', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Measured by continuous polysomnography (min)'}, {'measure': 'Low Frequency / High Frequency Band', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Mean LF/HF ratio measured by continuous ECG'}, {'measure': 'Standard Deviation 1 / Standard Deviation 2', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Mean SD1/SD2 ratio measured by continuous ECG'}, {'measure': 'RR intervals longer than 50 ms', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Percentage pNN50 measured by continuous ECG (%)'}, {'measure': 'Core Body Temperature', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Mean temperature measured by continuous double sensor monitoring (°C)'}, {'measure': 'Skin Temperature', 'timeFrame': 'During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Mean temperature measured by continuous double sensor monitoring (°C)'}, {'measure': 'Digit Span Task', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Longest memorized digit series (n, normal range 5-9, higher is better)'}, {'measure': 'Psychomotor Vigilance Task Subscale 1', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Number of lapses (normal range 0-6, higher is worse)'}, {'measure': 'Psychomotor Vigilance Task Subscale 2', 'timeFrame': 'After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Mean reaction time (normal range 100-500 ms, higher is worse)'}, {'measure': 'Color Stroope Task Subscale 1', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Number of incongruency errors (normal range 0-5, higher is worse)'}, {'measure': 'Color Stroope Task Subscale 2', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Congruent response time (normal range 400-500 ms, higher is worse)'}, {'measure': 'Color Stroope Task Subscale 3', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Incongruent response time (normal range 600-800 ms, higher is worse)'}, {'measure': 'Color Stroope Task Subscale 4', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Congruent accuracy (above 95% is normal, higher is better)'}, {'measure': 'Color Stroope Task Subscale 5', 'timeFrame': 'After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)', 'description': 'Incongruent accuracy (above 85% is normal, higher is better)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Sleep', 'Heart rate variability', 'Sleep architecture'], 'conditions': ['Hypoxia', 'Sleep', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '35685284', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.frontiersin.org/articles/10.3389/fphys.2022.899636/full', 'label': 'Results publication'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* Age 25-45 years\n* BMI 20 - 28 kg/m\\^2\n\nExclusion Criteria:\n\n* Severe, manifest illnesses in need of treatment\n* Postoperative phases\n* Acute and chronic infections\n* Sleep disorders such as sleep apnea, insomnia or somnolence\n* Altitude exposure (\\> 2500 m asl) within 6 months before enrollment\n* Regular migraines\n* Smoking\n* Athletes\n* Significant weight change within 1 month before enrollment\n* Inability to understand significance and scope of the study\n* Drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT04146857', 'acronym': 'NAPOXIA', 'briefTitle': 'Autonomic Activity During Nap Under Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)', 'orgStudyIdInfo': {'id': 'NAPOXIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normoxia', 'description': '20.9% oxygen', 'interventionNames': ['Other: Normoxia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypoxia 1', 'description': '15.0% oxygen', 'interventionNames': ['Other: Hypoxia 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypoxia 2', 'description': '12.8% oxygen', 'interventionNames': ['Other: Hypoxia 2']}], 'interventions': [{'name': 'Normoxia', 'type': 'OTHER', 'description': 'Nap in hypoxia chamber at 20.9% oxygen (36 m asl)', 'armGroupLabels': ['Normoxia']}, {'name': 'Hypoxia 1', 'type': 'OTHER', 'description': 'Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)', 'armGroupLabels': ['Hypoxia 1']}, {'name': 'Hypoxia 2', 'type': 'OTHER', 'description': 'Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)', 'armGroupLabels': ['Hypoxia 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Experimental & Clinical Research Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Anja Mähler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Alain Riveros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anja Maehler', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}