SATPC0041243 Tab 04 4 SOW.pdf

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10 Nox T3s sleep‑monitoring systems with accessories and training services. Federal contract opportunity
Solicitation number
80NSSC26934158Q
Issued by
National Aeronautics and Space Administration Shared Services Center

About this file

This is a Statement of Work (SOW) for the Fatigue Countermeasures Laboratory (Human Systems Integration Division - Code TH) at NASA to procure 10 Nox T3 home sleep test (HST) devices for a project titled "Revising the Exploration Atmosphere Hypoxia Limit to Mitigate Decompression Sickness During Surface EVA." The project is a critical initiative supporting Artemis objectives and is being conducted in collaboration with NASA Johnson Space Center (JSC).

The procurement requires 10 Nox T3 devices at an estimated total cost of $70,000, with Nox Medical identified as the supplier (https://noxmedical.com/). Two devices will be shipped to NASA Ames Research Center and eight devices to JSC. The devices will measure respiratory function during sleep to evaluate the impact of hypoxia on sleep outcomes, including apnea-hypopnea index, sleep architecture (REM/NREM stages), and actigraphy data. Participants will wear the Nox T3 devices for the first three nights and then every other night throughout the study, with continuous actigraphy monitoring and cognitive function testing conducted at least three times daily on alternating days. The project received authority to proceed on April 22, with NASA leadership requesting completion of the first phase by September 30, 2026. Expedited approval is requested to ensure equipment delivery by May 15 to allow time for testing and implementation of the devices for this high-priority study.

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V. 08.23.22

Statement of Work Human Systems Integration Division

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BACKGROUND

Project Title: Revising the Exploration Atmosphere Hypoxia Limit to Mitigate Decompression Sickness During Surface EVA

The Fatigue Countermeasures Laboratory (Human Systems Integration Division - Code TH) will purchase 10 Nox T3 home sleep test (HST)devices used to measure respiratory function during sleep as part of a project in collaboration with NASA JSC.

There are a number of effects of hypoxia on sleep. Respiratory function is altered during sleep at altitude or in hypobaric chambers simulating sleep at altitude. Sleeping at elevations as low as 1630 m can modestly increase the apnea-hypopnea index (AHI) and disrupt sleep (Lashtang et al. 2013), while sleep at higher elevations induces periodic breathing with apneas (West et al. 1986; Salvaggio et al. 1998; Reite et al. 1975). Males appear to be much more susceptible to the negative respiratory effects experienced at altitude, with males experiencing an increase in the apnea-hypopnea index that is more than 10 times greater that of females at 3400 m (Lombardi et al. 2013). The respiratory disturbances that occur at altitude usually reduce after a few nights of exposure, although some studies suggest that it can take more than a week for symptoms to resolve in some individuals (Lombardi et al. 2013), with it taking more than a month for some at altitudes over 5000 m. Oxygen supplementation is an effective countermeasure for reducing periodic breathing with apneas (Reite et al. 1975; Luks et al. 1998).

Hypoxia also appears to alter sleep architecture. Studies consistently demonstrate that slow-wave sleep is reduced during sleep at altitude (Salvaggio et al. 1998; Selvamurthy et

al. 1986; Miller and Horvath 1977; Reite et al. 1975; Barash et al. 2001; Lashtang et al.

2013). This may because respiratory disturbances result in arousals that interfere with the maintenance of slow-wave sleep (Reite et al. 1975; Salvaggio et al., 1998). The impact of sleeping at altitude on other sleep stages is mixed, with most studies reporting no changes, although two studies reported more transitions to light sleep (Reite et al., 1975; Miller and Horvath 1977), with one study reporting a reduction in REM sleep at 4500 m (de Aquino Lemos et al., 2012). Few studies have examined changes in sleep architecture over time at altitude, but one study reported that the reduction in slow-wave sleep observed at 3500 m persisted for two weeks after the return to sea level (Selvamurthy et al. 1986).

Interestingly, most studies have not found reductions in sleep duration, measured via polysomnography or actigraphy, during sleep at altitude compared to sleep at sea level (Salvaggio et al. 1998; Selvamurthy et al. 1986; Miller and Horvath 1977; Reite et al. 1975;

Barash et al. 2001), although one study reported a modest reduction in sleep duration after one night in a hypobaric chamber simulation of 4500 m (de Aquino Lemos et al. 2012).

While there are clear and measurable differences in respiratory function and sleep architecture during sleep at altitude, the effects of altitude-related sleep disruption on performance are less clear. Some studies have not observed changes in performance at elevations of 1630 m, 2590 m, and 3800 m (Luks et al. 1998; Lashtang et al. 2013), although it is possible that these null findings were due to the methodology used (e.g., frequency and timing of tests). A separate study found differences in several domains of performance, including attention, working memory, executive function, inhibitory control, and processing speed at 4500 m compared to sea level (de Aquino Lemos et al. 2012), while a different study suggests that sleep deprivation worsens performance to a greater extent at altitude compared to at sea level (Mertens and Collins, 1986).

Collectively, these studies highlight the importance of measuring changes in respiratory variables during sleep, ideally also including measurement of sleep staging to assess changes in sleep architecture. These studies also suggest that it is important to evaluate cognition at intervals frequent enough to capture any potential impacts of sleep disturbance on performance.

OBJECTIVE or REQUIREMENTS

Sleep-related Aims

1. We aim to characterize the impact of hypoxia on respiratory outcomes during sleep.

a. We further aim to characterize the time course of adaptation to hypoxia and to identify interindividual or sex differences.

b. We aim to collect exploratory data on REM/NREM sleep architecture using a novel algorithm to discriminate these global stages.

2. We aim to compare actigraphy to respiratory measures to determine whether respiratory-related arousals can be detected through movement.

Sleep-related Methods

Respiratory outcomes. Participants will wear the Nox T3 (or a similar device) for the first three nights and then every other night to evaluate respiratory function during sleep. This will allow us to evaluate acute changes in respiratory function in response to hypoxia and it will also enable us to evaluate the time course of adaptation to the hypoxic environment.

This device is frequently used by clinicians to conduct at-home sleep apnea tests, making it easy to use compared to a traditional laboratory polysomnography. The Nox T3 has been validated in clinical settings and is accurate and reliable for detecting apneas and hypopneas. The apnea-hypopnea index is calculated using a validated automated scoring algorithm. The Nox T3 does not include electroencephalography, which is the gold-standard for measuring sleep architecture, but it does include algorithms to estimate REM and non-REM sleep, providing some data to evaluate sleep architecture.

Actigraphy. Participants will wear actigraphy continuously. This will enable us to compare nights when respiratory function is not measured to nights when it is measured to identify potential variations in night-to-night sleep. We will also be able to compare arousals in the actigraphy data to arousals captured by the Nox T3 to determine whether actigraphy could be used to detect respiratory-related arousals during future missions.

Cognitive function. Participants will collect cognitive tests at least three times per day every other day throughout the study.

Estimated Cost: $70,000 (10 devices)

Companies Identified: Nox Medical (https://noxmedical.com/)

Environmental:

Additional request: 2 devices will be shipped to Ames; 8 devices will be shipped to JSC

PLACE OF PERFORMANCE

NASA AMES RESEARCH CENTER

JOHNSON SPACE CENTNER

PERIOD OF PERFORMANCE

The project: "Revising the Exploration Atmosphere Hypoxia Limit to Mitigate Decompression Sickness During Surface EVA” has been determined to be a critical project to the advancement of Artemis objectives. Although the project only received the authority to proceed on April 22, NASA leadership have requested that the first phase of the project is completed by September 30th, 2026. In order to receive, test, and implement the equipment for this high priority study, we request expedited approval to ensure delivery of the equipment by May 15th.

References

Latshang TD, Lo Cascio CM, Stöwhas AC, Grimm M, Stadelmann K, Tesler N, Achermann P, Huber R, Kohler M, Bloch KE. Are nocturnal breathing, sleep, and cognitive performance impaired at moderate altitude (1,630–2,590 m)?. Sleep. 2013 Dec 1;36(12):1969-76.

West JB, Peters Jr RM, Aksnes GU, Maret KH, Milledge JS, Schoene RB. Nocturnal periodic breathing at altitudes of 6,300 and 8,050 m. Journal of applied physiology. 1986 Jul 1;61(1):280-7.

https://noxmedical.com/ Bathurst, Nick (ARC-TH) What do i put here?

Salvaggio A, Insalaco G, Marrone O, Romano S, Braghiroli A, Lanfranchi P, Patruno V, Donner CF, Bonsignore G. Effects of high-altitude periodic breathing on sleep and arterial oxyhaemoglobin saturation. European Respiratory Journal. 1998 Aug 1;12(2):408-13.

Reite M, Jackson D, Cahoon RL, Weil JV. Sleep physiology at high altitude.

Electroencephalography and clinical neurophysiology. 1975 May 1;38(5):463-71.

Lombardi C, Meriggi P, Agostoni P, Faini A, Bilo G, Revera M, Caldara G, Di Rienzo M, Castiglioni P, Maurizio B, Gregorini F. High‐altitude hypoxia and periodic breathing during sleep: gender‐related differences. Journal of sleep research. 2013 Jun;22(3):322-30.

Luks AM, van Melick H, Batarse RR, Powell FL, Grant I, West JB. Room oxygen enrichment improves sleep and subsequent day-time performance at high altitude. Respiration physiology. 1998 Sep 1;113(3):247-58.

Selvamurthy W, Raju VR, Ranganathan S, Hegde KS, Ray US. Sleep patterns at an altitude of 3500 metres. International journal of biometeorology. 1986 Jun;30(2):123-35.

Miller JC, Horvath SM. Sleep at altitude. Aviation, space, and environmental medicine. 1977 Jul 1;48(7):615-20.

Barash IA, Beatty C, Powell FL, Prisk GK, West JB. Nocturnal oxygen enrichment of room air at 3800 meter altitude improves sleep architecture. High altitude medicine & biology. 2001 Dec 1;2(4):525-33.

de Aquino Lemos V, Antunes HK, Dos Santos RV, Lira FS, Tufik S, de Mello MT. High altitude exposure impairs sleep patterns, mood, and cognitive functions. Psychophysiology. 2012 Sep;49(9):1298-306.

Mertens HW, Collins WE. The effects of age, sleep deprivation, and altitude on complex performance. Human factors. 1986 Oct;28(5):541-51.

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