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Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

Primary Purpose

Sleep-Disordered Breathing, Glucose Intolerance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compressed Air
Supplemental Oxygen
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep-Disordered Breathing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Permanent residents of Puno, Peru

Exclusion Criteria:

  • Recent travel to low altitude (<3000 m)
  • Oxygen use
  • Pregnancy
  • Morbid obesity (BMI > 40 kg/m2)
  • Current smoking
  • Diabetes
  • Other sleep disorders (e.g. circadian rhythm disorder or insomnia)
  • Use of open fires in the home (i.e. for cooking or heat)
  • Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation < 85%, Qinghai CMS >10 or excessive erythrocytosis as defined by hemoglobin >19 g/dL in women or >21 g/dL in men.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Compressed Air then Supplemental Oxygen

    Supplemental Oxygen then Compressed Air

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean glucose level
    average glucose (mg/dL) during sleep assessed via continuous glucose monitoring

    Secondary Outcome Measures

    Mean fasting glucose level
    Mean fasting glucose level (mg/dL)
    Mean fasting insulin
    Fasting insulin (U/mL)
    Morning blood pressure
    Morning blood pressure (mmHg)
    Inflammatory marker interleukin-6 (IL-6)
    Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation
    Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
    Tumor Necrosis Factor alpha level in blood as a marker of inflammation
    C-Reactive Protein (CRP) level in blood (mg/L)
    C-Reactive Protein (CRP) level in blood as a marker of inflammation

    Full Information

    First Posted
    July 14, 2022
    Last Updated
    August 14, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    National Institutes of Health (NIH), PRISMA A.B., National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05462834
    Brief Title
    Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
    Official Title
    Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2027 (Anticipated)
    Study Completion Date
    November 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    National Institutes of Health (NIH), PRISMA A.B., National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations. The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep-Disordered Breathing, Glucose Intolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    2 intervention periods lasting 14 days, separated by a 7-day washout
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Compressed Air then Supplemental Oxygen
    Arm Type
    Experimental
    Arm Title
    Supplemental Oxygen then Compressed Air
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Compressed Air
    Intervention Description
    Participants will be instructed to use compressed air during sleep as a placebo control.
    Intervention Type
    Other
    Intervention Name(s)
    Supplemental Oxygen
    Intervention Description
    Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.
    Primary Outcome Measure Information:
    Title
    Mean glucose level
    Description
    average glucose (mg/dL) during sleep assessed via continuous glucose monitoring
    Time Frame
    14 days after start of intervention
    Secondary Outcome Measure Information:
    Title
    Mean fasting glucose level
    Description
    Mean fasting glucose level (mg/dL)
    Time Frame
    14 days after start of intervention
    Title
    Mean fasting insulin
    Description
    Fasting insulin (U/mL)
    Time Frame
    14 days after start of intervention
    Title
    Morning blood pressure
    Description
    Morning blood pressure (mmHg)
    Time Frame
    14 days after start of intervention
    Title
    Inflammatory marker interleukin-6 (IL-6)
    Description
    Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation
    Time Frame
    14 days after start of intervention
    Title
    Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
    Description
    Tumor Necrosis Factor alpha level in blood as a marker of inflammation
    Time Frame
    14 days after start of intervention
    Title
    C-Reactive Protein (CRP) level in blood (mg/L)
    Description
    C-Reactive Protein (CRP) level in blood as a marker of inflammation
    Time Frame
    14 days after start of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Permanent residents of Puno, Peru Exclusion Criteria: Recent travel to low altitude (<3000 m) Oxygen use Pregnancy Morbid obesity (BMI > 40 kg/m2) Current smoking Diabetes Other sleep disorders (e.g. circadian rhythm disorder or insomnia) Use of open fires in the home (i.e. for cooking or heat) Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation < 85%, Qinghai CMS >10 or excessive erythrocytosis as defined by hemoglobin >19 g/dL in women or >21 g/dL in men.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luu Pham, MD
    Phone
    4105502118
    Email
    lpham1@jhmi.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luu Pham, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

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