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Completed

NCT Number: NCT01523691

Repeating Patterns of Sleep Restriction and Recovery

Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) between 18.5 and 30 kg/m2
  • For female participants: regular menstrual cycles
  • Daily sleep duration in the normal range
  • Blood chemistry in the normal range

Exclusion criteria

  • Active infection/disease
  • History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
  • Pregnant/nursing
  • Respiratory disturbance index of >5 events/hour on polysomnographic sleep study, leg movements with arousal >10/hour; sleep efficiency <80%
  • Regular medication use other than oral contraceptives
  • Donation of blood or platelets 3 month prior to or in-between study arms

Treatment and study plan

Repeated sleep restriction and recovery

Behavioral

Repeated cycles of sleep restriction and sleep recovery

Control sleep

Behavioral

Regular amounts of sleep across study protocol

Primary outcomes

  1. stress-related markers

    Time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.

    cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others

Secondary outcomes

  1. subjective stress-related markers

    Time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.

    Computerized rating scales for the assessment of physical and emotional well-being

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 1, 2012
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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